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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer

NCT02651142

Breast Cancer

UNKNOWN NA

Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

NCT01137097

Thyroid Neoplasm

COMPLETED PHASE2/PHASE3

Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer

NCT02168452

Breast Cancer

COMPLETED

To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes

NCT03715686

Neoplasm, Breast Neoadjuvant Chemotherapy Lymph Node Metastases +1 more

UNKNOWN NA

Molecular Marker Profiling of Axillary Lymph Nodes in Predicting Response in Patients With Locally Advanced or Metastatic Breast Cancer Who Are Undergoing Chemotherapy Followed By Surgery

NCT00233974

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Papillary Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No