Thyroid Nodule Clinical Trial
Official title:
Role of NGS-based ThyroSeq Panel in Cancer Diagnosis in Thyroid Nodules
Verified date | July 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow
inexpensive testing for hundreds of mutational hotspots at the same time. A number of
additional mutational markers in thyroid cancer have been identified. Highly promising
markers associated with tumor prognosis have also been found. This multi-institutional study
aims to validate the diagnostic use of mutational markers in thyroid nodules with
indeterminate cytology.
The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large
panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer
risk stratification in thyroid nodules.
The performance of the panel will be tested in a multi-institutional double-blind prospective
study of FNA samples from thyroid nodules with indeterminate cytology and available surgical
outcome
Status | Completed |
Enrollment | 256 |
Est. completion date | February 15, 2019 |
Est. primary completion date | February 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients that undergo a clinically diagnostic thyroid FNA Exclusion Criteria: - Children - pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Duke University, Johns Hopkins University, Ohio State University, University of Cincinnati, University of Colorado, Denver, University of Pennsylvania, University of Wisconsin, Madison, Washington Hospital Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcomes | The primary outcome measured in this study is the performance (sensitivity, specificity, NPV, PPV) of the Thyroseq Panel in diagnosing cancer in thyroid nodules with Bethesda III, VI and V cytology. | April 2016 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04614389 -
Utility of Contrast-Enhanced Sonography and Shear Wave Elastography
|
N/A | |
Recruiting |
NCT03295955 -
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
|
N/A | |
Completed |
NCT04647006 -
Comparison of TOETVA and Conventional Thyroidectomy
|
N/A | |
Not yet recruiting |
NCT06029946 -
B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
|
||
Recruiting |
NCT05025046 -
NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
|
||
Terminated |
NCT01320813 -
Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
|
N/A | |
Completed |
NCT00877630 -
Minimal Invasiveness of Endoscopic Thyroidectomy
|
N/A | |
Completed |
NCT01964508 -
microRNA in Thyroid Cancer
|
||
Completed |
NCT06306599 -
Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial
|
N/A | |
Recruiting |
NCT04730726 -
In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
|
N/A | |
Not yet recruiting |
NCT03884140 -
Clinical Diagnostic Approach for Cases of Thyroid Nodules
|
||
Completed |
NCT04277455 -
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
|
N/A | |
Recruiting |
NCT02225509 -
Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology
|
N/A | |
Completed |
NCT00552253 -
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
|
N/A | |
Not yet recruiting |
NCT03700762 -
Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
|
||
Enrolling by invitation |
NCT01757834 -
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
|
N/A | |
Completed |
NCT01292044 -
The Role of Elastography in the Diagnosis of Thyroid Nodules
|
N/A | |
Completed |
NCT00858104 -
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
|
Phase 4 | |
Completed |
NCT00651625 -
Reciprocating Medical Devices - a Study of a New Safety Device
|
N/A | |
Completed |
NCT05132478 -
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
|
N/A |