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OpenTrials
Completed

NCT Number: NCT02442661

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 13, 2015
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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