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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome:

  • 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 ]
  • 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 ]


Original Primary Outcome:

  • Detection of lymph node metastasis in a newly diagnosed patient with Papillary Thyroid Cancer at baseline neck ultrasound by radiologist's standard assessment method (Ir test). [ Time Frame: 6 months ]
  • Detection of lymph node metastasis in a newly diagnosed patient with Papillary Thyroid Cancer at the baseline neck ultrasound by predictive model method (Im test). [ Time Frame: 6 months ]


Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: April 22, 2015
Date Started: April 1, 2015
Date Completion: May 31, 2017
Last Updated: May 3, 2017
Last Verified: May 2017