NTRK 1,2,3 Rearrangements in Patients With Solid Tumors (NTRK)

This study aims to evaluate the incidence of NTRK rearrangements in patients with solid tumors in Italy. Additionally, the study seeks to define the correlation between IHC and FISH testing and to simplify the assessment of NTRK rearrangements in patients with solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: NTRK1/2/3 Fusion Gene Detection

Detailed Description

Neurotrophic tropomyosin-related kinases (NTRKs, or the commonly used alias TRKs) constitute a receptor tyrosine kinase family of neurotrophin receptors involved in neuronal development, including the growth and function of neuronal synapses and memory development.

NTRK1/2/3 gene fusions have emerged as new targets for cancer therapy as they can be successfully inhibited by targeted kinase inhibitors. Several compounds targeting TRKs are currently being explored in clinical trials and, notably, one of these compounds, larotrectinib (VITRAKVI®), has received accelerated approval by the United States Food and Drug Administration (FDA) for adult and paediatric solid tumours with a NTRK fusion without known resistance mutations. In addition, entrectinib has received breakthrough designation status by the United States FDA for the treatment of cancers types harbouring NTRK fusions. Hence, there is an active interest in clinical oncology for NTRK fusions, which has prompted an urgent need to define the routine diagnostic test to identify gene fusions as a companion diagnostic method to support clinical decision in this context. Irrespective of the method adopted for NTRK detection, high activity of anti-NTRK agents and therefore the necessity to guarantee these agents to all NTRK+ patients, strongly supports a NTRK screening program for patients with cancer.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 000144
      • Grisel Maver Militello
    • Roma, RM, Italy, 00144
      • Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with solid tumors, irrespective of tumor stage.

Description

Inclusion Criteria:

• Histological diagnosis of any solid cancer
• Availability of tumor tissue for biomarker analyses (at least 5 slides, 4 micron)
• Signed informed consent form

Exclusion Criteria:

• No tumor tissue available

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the incidence of NTRK rearrangements in patients with solid tumors in Italy	Tumor tissue slides (4 micron) will be tested for NTRK positivity by means of immunohistochemistry (IHC) and then confirmed by means of fluorescence in-situ hybridization (FISH).	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define incidence of NTRK in different tumor types	The incidence of NTRK gene fusions across different tumor types involves determining how frequently these genetic alterations occur within various malignancies. This process is essential for understanding the potential role of targeted therapies, such as TRK inhibitors, in specific cancers	36 months

Collaborators and Investigators

• Sponsor: Federico Cappuzzo
• Collaborators: Bayer
• Investigators: Principal Investigator: Federico Cappuzzo, PI, Fondazione FORT

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: NTRK
• Other Study ID Numbers: NTRK (Other Identifier: Fondazionefort)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No