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Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT02442661
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. Standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. In the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Results of both the standard and research method will be used to decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. It is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.

Condition or disease
Papillary Thyroid Cancer

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2017

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Primary Outcome Measures :
  1. Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by radiologist's standard assessment method (Ir test). [ Time Frame: 6 months ]
  2. Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by predictive model method (Im test). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Confirmation of the lymph node metastasis by fine needle aspiration biopsy prior to the surgery. [ Time Frame: 6 months ]
  2. Measure true positive and false positive results of Ir test and Im test for comparison. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-thyroidectomy patients with a pathological diagnosis of Papillary Thyroid Cancer (PTC) who undergo cervical lymph node evaluation for detection of locoregional metastasis will be included in this study.
Criteria

Inclusion Criteria:

  • Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes.
  • Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results.
  • All patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam.

Exclusion Criteria:

  • Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice.
  • Lymph node less than 5 mm in short axis on ultrasound.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442661


Locations
United States, Colorado
Rebecca J Guigli
Aurora, Colorado, United States, 80014
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Nayana Patel, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02442661     History of Changes
Other Study ID Numbers: 14-2053
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data is only available to study personnel

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type