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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Stage I Papillary Thyroid Cancer
Stage II Papillary Thyroid Cancer
Stage III Papillary Thyroid Cancer
Interventions Procedure: Thyroidectomy
Procedure: entral lymph node dissection (CLND)
Other: Quality-of-life assessment
Enrollment 117
Recruitment Details  
Pre-assignment Details 117 participants consented. 27 participants were excluded from the study before assignment to arms (15 participants withdrew before surgery, 12 participants did not meet intraoperative inclusion criteria). 90 participants were allocated in 3 arms
Arm/Group Title Arm I (no CND) Arm II (CND) Arm III (SOC)
Hide Arm/Group Description

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

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

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Period Title: Overall Study
Started 30 30 30
Analyzed for Baseline Measures 30 29 30
Completed 30 26 26
Not Completed 0 4 4
Reason Not Completed
Withdrawal by Subject             0             1             0
Lost to Follow-up             0             2             4
Screen Failure             0             1             0
Arm/Group Title Arm I (no CND) Arm II (CND) Arm III (SOC) Total
Hide Arm/Group Description

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

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

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Total of all reporting groups
Overall Number of Baseline Participants 30 29 30 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 30 participants 89 participants
46.10  (1.47) 50.07  (2.38) 43.17  (2.68) 46.40  (1.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 30 participants 89 participants
Female
23
  76.7%
21
  72.4%
27
  90.0%
71
  79.8%
Male
7
  23.3%
8
  27.6%
3
  10.0%
18
  20.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 30 participants 89 participants
Hispanic or Latino
1
   3.3%
0
   0.0%
2
   6.7%
3
   3.4%
Not Hispanic or Latino
29
  96.7%
29
 100.0%
28
  93.3%
86
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 30 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   6.7%
2
   2.2%
Asian
0
   0.0%
1
   3.4%
0
   0.0%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
30
 100.0%
28
  96.6%
27
  90.0%
85
  95.5%
More than one race
0
   0.0%
0
   0.0%
1
   3.3%
1
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 30 participants 89 participants
30 29 30 89
1.Primary Outcome
Title Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml
Hide Description Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.
Time Frame Post-operative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in the Arm II(CND) was a screen failure. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: percentage of participants
24.1 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments p-value threshold for statistical significance is 0.05
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Post-operative Serum Calcium (mg/dL) at Day 12
Hide Description Post-operative serum calcium (mg/dL) at Day 12
Time Frame At day 12
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in the Arm II(CND) was a screen failure. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 29 30
Mean (Standard Error)
Unit of Measure: mg/dL
9.39  (0.12) 9.13  (0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Total Calcium Consumption in First 2 Weeks
Hide Description 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.
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants in CND arm, 22 in 'no CND' arm returned their calcium symptom log to study staff at the end of the postoperative follow-up period. Missing data is due to participants losing/forgetting to return their calcium symptom logs/lack of clarity in their handwritten log entries. This may also have led to limited reliability/accuracy of the data we were able to collect. SOC arm data was not collected as outcome is a comparison of complication rates between TT and CND arms, N/A to SOC arm.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 19 22
Mean (Standard Error)
Unit of Measure: mg
21876.63  (6353.42) 25470.19  (6592.60)
4.Primary Outcome
Title Number of Participants With Hypocalcemia Symptoms in First 2 Weeks
Hide Description

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

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
In Arm II (CND) 1 participant was lost to screen failure, 1 self-withdrew. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
8 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.758
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Primary Outcome
Title Hypocalcemia Symptom Severity Scale (Range of 1-5)
Hide Description 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).
Time Frame 2 weeks post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data is due to participants losing/forgetting to return their calcium symptom logs/lack of clarity in their handwritten log entries. This may also have led to limited reliability/accuracy of the data we were able to collect. SOC arm data was not collected as outcome is a comparison of complication rates between TT and CND arms, not applicable (N/A) to SOC arm.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 13 19
Mean (Standard Error)
Unit of Measure: occurrences
mild symptoms (severity 1 - 2) 3  (1.49) 2.50  (0.81)
severe symptoms (severity 3 - 5) 3.36  (1.59) 1.42  (0.73)
6.Primary Outcome
Title Percentage of Participants That Required Calcium and Calcitriol at Month 6
Hide Description Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH <15 pg/ml)
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
In Arm II (CND) 1 participant was lost to screen failure, 1 self-withdrew, 1 was lost to follow up. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 27 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  10.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Primary Outcome
Title Post-operative Serum PTH (pg/ml) at Month 6
Hide Description [Not Specified]
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
In Arm II (CND) 1 participant was lost to screen failure, 1 self-withdrew, 1 was lost to follow up. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 27 30
Mean (Standard Error)
Unit of Measure: pg/mL
45.62  (4.6) 44.24  (4.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.759
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Primary Outcome
Title Post-operative Serum Calcium Level at Month 6
Hide Description Post-operative serum calcium (mg/dL) at Month 6
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
In Arm II (CND) 1 participant was lost to screen failure, 1 self-withdrew, 1 was lost to follow up. Arm III(SOC) data was not collected for this outcome measure as outcome is a comparison of complication rates between TT and CND arms and does not apply to SOC arm participants. The SOC arm was added later as comparison for the qualitative aims only.
Arm/Group Title Arm II (CND) Arm I (no CND)
Hide Arm/Group Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Overall Number of Participants Analyzed 27 30
Mean (Standard Error)
Unit of Measure: mg/dL
9.12  (0.08) 8.98  (0.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II (CND), Arm I (no CND)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.400
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Rate of Transient and Permanent Hypocalcemia
Hide Description

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.

Time Frame Post-operative day 1 - Month 6
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Rate of Voice and Swallowing Problems
Hide Description

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.

Time Frame Post operative day 1 - up to 1 year
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Degree to Which Quality of Life (QOL) is Compromised
Hide Description

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.

Time Frame Post-operative day 1 - up to 1 year
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Clinical Recurrence Rates
Hide Description

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.

Time Frame Week 6 - up to 5 years
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques
Hide Description 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.
Time Frame Post-operative day 1 - up to 1 year
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (no CND) Arm II (CND) Arm III (SOC)
Hide Arm/Group Description

Patients undergo total thyroidectomy alone.

Thyroidectomy: Undergo total thyroidectomy

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Thyroidectomy: Undergo total thyroidectomy

Central lymph node dissection: Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

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

Quality-of-life assessment: Voice evaluation, interviews, ancillary studies

All-Cause Mortality
Arm I (no CND) Arm II (CND) Arm III (SOC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/29 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Arm I (no CND) Arm II (CND) Arm III (SOC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/29 (0.00%)      0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (no CND) Arm II (CND) Arm III (SOC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/30 (76.67%)      25/29 (86.21%)      9/30 (30.00%)    
Injury, poisoning and procedural complications       
biochemical hypopcalcemia * [1]  2/30 (6.67%)  2 0/29 (0.00%)  0 1/30 (3.33%)  1
symptomatic hypoparathyroidism * [2]  2/30 (6.67%)  2 4/29 (13.79%)  4 1/30 (3.33%)  1
nerve injury * [3]  12/30 (40.00%)  12 7/29 (24.14%)  7 3/30 (10.00%)  3
significant voice changes not otherwise characterized * [4]  11/30 (36.67%)  11 7/29 (24.14%)  7 2/30 (6.67%)  2
biochemical hypoparathyroidism * [5]  9/30 (30.00%)  9 8/29 (27.59%)  8 3/30 (10.00%)  3
symptomatic hypocalcemia * [6]  4/30 (13.33%)  4 6/29 (20.69%)  6 2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Serum calcium <8.0 mg/dL at any single time point
[2]
The need for calcium or calcitriol to prevent symptoms of hypocalcemia Evidenced by paresthesias and/or muscle cramps which are improved or relieved with calcium Requiring frequent treatment with calcium and vitamin D
[3]
Injury to or dysfunction of the recurrent laryngeal nerve (RLN) or superior laryngeal nerve (SLN) as complication of thyroid surgery
[4]
If patient needs further voice evaluations beyond two-week time point, this is indication of significant voice change(s)
[5]
Serum PTH level <10 pg/ml
[6]
Significant symptomatic hypocalcemia
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rebecca Sippel
Organization: University of Wisconsin, Madison
Phone: 608-263-1387
EMail: sippel@surgery.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02138214    
Other Study ID Numbers: 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 )
First Submitted: May 12, 2014
First Posted: May 14, 2014
Results First Submitted: October 26, 2020
Results First Posted: December 21, 2020
Last Update Posted: December 21, 2020