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Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138214
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Results First Submitted Date  ICMJE October 26, 2020
Results First Posted Date  ICMJE December 21, 2020
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE June 6, 2014
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml [ Time Frame: Post-operative day 1 ]
    Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.
  • Post-operative Serum Calcium (mg/dL) at Day 12 [ Time Frame: At day 12 ]
    Post-operative serum calcium (mg/dL) at Day 12
  • Total Calcium Consumption in First 2 Weeks [ Time Frame: 2 weeks after surgery ]
    Total calcium consumption in first 2 weeks (total mg). Participants were given calcium symptom logs in which to record their calcium consumption between surgery and their first preoperative follow up appointment, approximately two week.
  • Number of Participants With Hypocalcemia Symptoms in First 2 Weeks [ Time Frame: 2 weeks ]
    Number of participants with hypocalcemia symptoms and symptom severity in first two weeks, as defined by presence of clinically significant symptoms of hypocalcemia. Clinically significant symptoms defined as 1 or more episodes of symptoms of hypocalcemia per day for multiple days, symptoms leading to calls to provider for assistance with managing and/or symptoms leading to escalation of dosage of prescribed medications to treat symptoms of hypocalcemia
  • Hypocalcemia Symptom Severity Scale (Range of 1-5) [ Time Frame: 2 weeks post surgery ]
    Mean number of occurrences of mild (severity 1 - 2) and severe (severity 3 - 5) hypocalcemia symptoms. Participants were asked to record hypocalcemia symptoms between surgery and first postoperative follow-up at approximately two weeks in their provided calcium symptom logs and rank severity on scale of 1 (mild) to 5 (severe).
  • Percentage of Participants That Required Calcium and Calcitriol at Month 6 [ Time Frame: At Month 6 ]
    Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH <15 pg/ml)
  • Post-operative Serum PTH (pg/ml) at Month 6 [ Time Frame: At Month 6 ]
  • Post-operative Serum Calcium Level at Month 6 [ Time Frame: At Month 6 ]
    Post-operative serum calcium (mg/dL) at Month 6
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • Rate of transient hypoparathyroidism, as defined by a day 1 serum parathyroid hormone (PTH) level of < 10 pg/ml [ Time Frame: Post-operative day 1 ]
    Data will be analyzed using a mixed model 2-way analysis of variance (ANOVA) examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Post-operative serum calcium level (mg/dL) [ Time Frame: Week 2 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Post-operative serum calcium level (mg/dL) [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Post-operative PTH (pg/ml) [ Time Frame: 2 weeks ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Post-operative PTH (pg/ml) [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Total calcium consumption in first 2 weeks (total gm) [ Time Frame: 2 weeks ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Average episodes of hypocalcemia symptoms per day [ Time Frame: 2 weeks ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Hypocalcemia symptom severity, measured by the Hypocalcemia symptom severity scale (range of 1-5) [ Time Frame: Up to 6 months ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Requirement for calcium [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Requirement for calcitriol [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • Rate of Transient and Permanent Hypocalcemia [ Time Frame: Post-operative day 1 - Month 6 ]
    The rate of transient and permanent hypocalcemia will be determined by assessing the following: I. Post-operative serum calcium (mg/dl) and PTH (pg/ml) at Day 12 and Month 6 II. Total calcium consumption in first 2 weeks (total gm) III. Hypocalcemia symptoms in first 2 weeks (average episodes/day) IV. Hypocalcemia symptom severity scale (range 1-5) V. Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH < 15 pg/ml Data will be analyzed using the methods described above.
  • Rate of Voice and Swallowing Problems [ Time Frame: Post operative day 1 - up to 1 year ]
    The rate of voice and swallowing problems will be determined by assessing the following: I. Phonation threshold pressure, in centimeters of water II. Dysphonia severity index (DSI) score (+5 to -5) III. Grade Roughness Breathiness Asthenia Strain (GRBAS) score (0-3) IV. Voice quality parameters as measured by Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) (0-100 on visual analog scale) V. Vocal fold vibratory and movement parameters as measured by stroboscopy assessment (1-4) VI. Glottal function index score VII. Penetration-Aspiration score as measured by videofluoroscopic swallow study (0-8) Data will be analyzed using the methods described above.
  • Degree to Which Quality of Life (QOL) is Compromised [ Time Frame: Post-operative day 1 - up to 1 year ]
    The degree to which quality (QOL) is compromised will be determined by assessing the following: I. Short Form Health Survey (SF-12) Mental Composite Scale (MCS) score II. Short Form Health Survey (SF-12) Physical Composite Scale (PCS) score III. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (C30) score IV. Thyroid Cancer Specific Quality of Life (ThyCA-QOL) score V. 10-item Eating Assessment Tool (EAT-10) dysphagia inventory score VI. Voice Handicap Index (VHI) score VII. Themes and codes from interview transcripts assessed using qualitative research methods Data will be analyzed using the methods described above.
  • Clinical Recurrence Rates [ Time Frame: Week 6 - up to 5 years ]
    Clinical recurrence rates will be determined by assessing the following: I. Percent of patients with a recombinant thyroid-stimulating hormone (rTSH) stimulated thyroglobulin level < 1 ng/ml one year after surgery II. Unstimulated thyroglobulin level prior to beginning week 6 radioactive iodine treatment III. Stimulated thyroglobulin at the time of week 6 radioactive iodine treatment IV. Incidence of unstimulated thyroglobulin > 1 ng/mL at 6 months V. Incidence of stimulated thyroglobulin > 2 ng/mL at 1 year VI. Incidence of biopsy-proven disease identification on neck ultrasound or iodine-131 (I-131) uptake up to 5 years post-surgery Data will be analyzed using the methods described above.
  • Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques [ Time Frame: Post-operative day 1 - up to 1 year ]
    The degree to which accurate quality of life (QOL) measures can be extracted from patient interview narratives using natural language process techniques will allow for the development of computer algorithms that convert patient narrative text into simple quality of life measures. Data will be analyzed using the methods described above.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • Phonation threshold pressure, in centimeters of water (dihydrogen monoxide [H2O]) [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Dysphonia Severity Index (DSI) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Grade Roughness Breathiness Asthenia Strain (GRBAS) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Voice quality parameters, assessed using Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Vocal fold vibratory and movement parameters, measured using stroboscopy assessment [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Glottal Function Index score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Penetration-Aspiration Scale from videofluoroscopic swallow study [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Short Form Health Survey (SF-12) Mental Composite Scale (MCS) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • SF-12 Physical Composite Scale (PCS) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (C30) scores [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Thyroid Cancer Specific Quality of Life (ThyCA-QOL) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • 10-item Eating Assessment Tool (EAT-10) dysphagia inventory score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Voice Handicap Index (VHI) score [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Themes and codes from interview transcripts, assessed using qualitative research methods [ Time Frame: Up to 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Percent of patients with a recombinant thyroid-stimulating hormone (rTSH) stimulated thyroglobulin level < 1 ng/ml [ Time Frame: 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Unstimulated thyroglobulin level prior to beginning week 6 radioactive iodine treatment [ Time Frame: Week 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Incidence of stimulated thyroglobulin at the time of week 6 radioactive iodine treatment [ Time Frame: Week 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Incidence of unstimulated thyroglobulin > 1 ng/mL [ Time Frame: Month 6 ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Incidence of stimulated thyroglobulin > 2 ng/mL [ Time Frame: 1 year ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
  • Incidence of biopsy-proven disease identification on neck ultrasound or iodine-131 (I-131) uptake [ Time Frame: Up to 5 years ]
    Data will be analyzed using a mixed model 2-way ANOVA examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Official Title  ICMJE Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
Brief Summary This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the rate of transient and permanent hypocalcemia

SECONDARY OBJECTIVES:

I. To determine the rate of voice and swallowing problems.

II. To determine the degree to which quality of life (QOL) is compromised.

III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques.

IV. To determine clinical recurrence rates.

OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.

Arm I: Patients undergo total thyroidectomy alone.

Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).

Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up.

After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage I Papillary Thyroid Cancer
  • Stage II Papillary Thyroid Cancer
  • Stage III Papillary Thyroid Cancer
Intervention  ICMJE
  • Procedure: Thyroidectomy
    Undergo total thyroidectomy
  • Procedure: entral lymph node dissection (CLND)
    Undergo total thyroidectomy with ipsilateral prophylactic CND
  • Other: Quality-of-life assessment
    Voice evaluation, interviews, ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (no CND)
    Patients undergo total thyroidectomy alone.
    Interventions:
    • Procedure: Thyroidectomy
    • Other: Quality-of-life assessment
  • Experimental: Arm II (CND)
    Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
    Interventions:
    • Procedure: Thyroidectomy
    • Procedure: entral lymph node dissection (CLND)
    • Other: Quality-of-life assessment
  • Active Comparator: Arm III (SOC)
    Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference
    Intervention: Other: Quality-of-life assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2020)
117
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2014)
140
Actual Study Completion Date  ICMJE October 26, 2020
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
  • No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
  • No evidence of distant metastases
  • Ability to read and write in English

Exclusion Criteria:

  • Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
  • Previous thyroid surgery
  • Concurrent active malignancy of another type
  • Inability to give informed consent or lacks decision making capacity
  • T4 tumor
  • Pre-existing vocal cord paralysis
  • Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
  • Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
  • Becomes pregnant before surgery or at any time while on study

INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only)

  • Evidence of nodal involvement identified in the operating room (OR)
  • Failure to confirm diagnosis of cancer in participant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138214
Other Study ID Numbers  ICMJE UW13115
NCI-2014-00833 ( Registry Identifier: NCI Trial ID )
UW13115 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
R01CA176911 ( U.S. NIH Grant/Contract )
2014-0391 ( Other Identifier: UW-Madison Health Sciences IRB )
A539700 ( Other Identifier: UW Madison )
SMPH\SURGERY\SURGERY ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Rebecca Sippel University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP