Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer

NCT05796258 | Completed

• 1 other identifier: RS1445/20(2421)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Thyroid Cancer

Keywords

ntrk fusion

Outcome Measures

Primary Outcomes (1)

• Frequency of NTRK fusions in thyroid cancer

  To assess the frequency of NTRK fusions in histological sample of tumors by patients affected by thyroid cancer, assessed as the number of tumor harboring NTRK fusion on the total of tumor analized

  from 01-Jan-2022 to 31-Dec-2023

Secondary Outcomes (2)

• Assesment of the ability of Immunohistochemistry to identify for NTRK fusion

  from 01-Jan-2022 to 31-Dec-2023

• Assesment of the ability of real time PCR to identify for NTRK fusion

  from 01-Jan-2022 to 31-Dec-2023

Interventions

NTRK fusion assessment DIAGNOSTIC_TEST

To evaluate NTRK fusion presence by MCG, Immunohistochemistry or NGS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by advanced thyroid cancer (any histotype)

You may qualify if:

• Diagnosis of advanced thyroid cancer (any histotype)
• Informed consent.

You may not qualify if:

• Patients with thyroid neoplasms without appropriate material for subsequent immunohistochemical and molecular studies;
• Patients with non-advanced thyroid cancer

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• University of Roma La Sapienza: collaborator
• Bambino Gesù Hospital and Research Institute: collaborator

Study Sites (1)

Regina Elena National Cancer Institute

Roma, 00144, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue is routinely obtained after the surgical removal of the tumor tissue (primary or metastatic). Part of the tissue will be immediately processed for RNA extraction, the rest of the tissue is processed for conventional histology/IHC analysis and stored in the institutional tissue biobank.

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Marialuisa Appetecchia, Prof

  Regina Elena Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 3, 2023
• Study Start: July 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After study end
• Access Criteria: open access

Locations

IT (1)