Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05796258 |
Other study ID # |
RS1445/20(2421) |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 26, 2021 |
Est. completion date |
June 30, 2024 |
Study information
Verified date |
April 2024 |
Source |
Regina Elena Cancer Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This multi-center study aims at NTRK fusion testing of all patients with advanced thyroid
cancer (any histotype and regardless of stage). The primary objective of this study is to
assess the frequency of NTRK fusions in thyroid cancer. The secondary objective of this study
is to develop an effective tool (testing) strategy for the detection of NTRK fusions in
thyroid tumors, comparing the diagnostic tecniques available (IHC, real-time PCR and NGS).
Description:
Thyroid cancer is the most common neoplasm of the endocrine system. Most thyroid carcinomas
originate from the follicular epithelium and are distinguished in differentiated forms (DTC):
papillary (PTC) and follicular (FTC) carcinomas. Both have a favorable prognosis and account
for approximately 80% and 10% of all thyroid neoplasms, respectively. The undifferentiated
form represented by the anaplastic thyroid carcinoma (ATC) is less frequent (about 2%) and
represents one of the most aggressive human tumors with a survival that rarely exceeds 6-12
months. Medullary thyroid carcinoma (MTC), deriving from parafollicular C cells, is
relatively rare (approximately 5%) and is associated with an intermediate prognosis between
differentiated and poorly differentiated forms.
As to the prevalence of NTRK lesions, many authoritative papers and reviews claim very high
(up to 75%) NTRK fusion frequencies, particularly in the common PTC. However, an extensive
PubMed analysis back to year 1990 does not provide convincing support for this claim.Several
techniques for NTRK fusion diagnosis exist, including pan-Trk IHC, FISH, reverse
transcription PCR, DNA-based next-generation sequencing (NGS), and RNA-based NGS. Each of
these assays has unique features, advantages, and limitations, and familiarity with these
assays is critical to appropriately screen for NTRK fusions.
The aim of this study is to determine the frequency of NTRK fusions in advanced thyroid
cancer patients and to compare the diagnostic tecniques available (IHC, real-time PCR and
NGS).