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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02442661
Collaborator
(none)
103
Enrollment
1
Location
25
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Apr 1, 2015
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    May 1, 2017

    Outcome Measures

    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). [6 months]

    2. 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

    1. Confirmation of the lymph node metastasis by fine needle aspiration biopsy prior to the surgery. [6 months]

    2. Measure true positive and false positive results of Ir test and Im test for comparison. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02442661
    Other Study ID Numbers:
    • 14-2053
    First Posted:
    May 13, 2015
    Last Update Posted:
    Jun 12, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Lymphatic Metastasis
    Thyroid Cancer, Papillary
    Thyroid Diseases

    Study Results

    No Results Posted as of Jun 12, 2017