Three-pronged Centralized Molecular Analysis to Optimize... | NCT05796258

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

NCT05796258

Sponsor

Regina Elena Cancer Institute

Status

Completed

Last Update Posted

Dec 5, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Thyroid Cancer

Interventions

NTRK fusion assessment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2021Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 4, 2024Actual

First Submitted Date

Mar 16, 2023

First Submission Date that Met QC Criteria

Mar 31, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marialuisa Appetecchia, Professor, Regina Elena Cancer InstitutePrincipal Investigator

Lead Sponsor

Regina Elena Cancer InstituteOTHER

Collaborators

Name	Class
University of Roma La Sapienza	OTHER
Bambino Gesù Hospital and Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NTRK fusion assessment	Diagnostic Test	To evaluate NTRK fusion presence by MCG, Immunohistochemistry or NGS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Assesment of the ability of Immunohistochemistry to identify for NTRK fusion	To assess the ability of Immunohistochemistry to detect NTRK fusion on histological sample (using NGS as comparator)	from 01-Jan-2022 to 31-Dec-2023
Assesment of the ability of real time PCR to identify for NTRK fusion

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients affected by advanced thyroid cancer (any histotype)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marialuisa Appetecchia, Prof	Regina Elena Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regina Elena National Cancer Institute		Roma		00144	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Raw data will be published in open access databases

Types

Study Protocol
Analytic Code

Time Frame

After study end

Access Criteria

open access

URL

http://garr.it

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.