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

Completed

• Conditions: Papillary Thyroid Cancer

• Registration Number: NCT02442661
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by radiologist's standard assessment method (Ir test).	6 months
Detection of lymph node metastasis in a patient with Papillary Thyroid Cancer by neck ultrasound by predictive model method (Im test).	6 months

Secondary Outcome Measures

Name	Time	Method
Confirmation of the lymph node metastasis by fine needle aspiration biopsy prior to the surgery.	6 months
Measure true positive and false positive results of Ir test and Im test for comparison.	6 months

Trial Locations

Locations (1)

Rebecca J Guigli; 🇺🇸 Aurora, Colorado, United States