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Trial Title:
Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer
NCT ID:
NCT05796258
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
ntrk fusion
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
NTRK fusion assessment
Description:
To evaluate NTRK fusion presence by MCG, Immunohistochemistry or NGS
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).
Detailed 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).
Criteria for eligibility:
Study pop:
Patients affected by advanced thyroid cancer (any histotype)
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Diagnosis of advanced thyroid cancer (any histotype)
- Informed consent.
Exclusion Criteria:
- Patients with thyroid neoplasms without appropriate material for subsequent
immunohistochemical and molecular studies;
- Patients with non-advanced thyroid cancer
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Regina Elena National Cancer Institute
Address:
City:
Roma
Zip:
00144
Country:
Italy
Start date:
July 26, 2021
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of Roma La Sapienza
Agency class:
Other
Collaborator:
Agency:
Bambino Gesù Hospital and Research Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05796258
