NTRK 1,2,3 Rearrangements in Patients With Solid Tumors (NTRK)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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RM
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Roma, RM, Italy, 000144
- Grisel Maver Militello
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Roma, RM, Italy, 00144
- Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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
Time Frame: 36 months
|
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).
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36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To define incidence of NTRK in different tumor types
Time Frame: 36 months
|
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
Collaborators
Investigators
- Principal Investigator: Federico Cappuzzo, PI, Fondazione FORT
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NTRK (Other Identifier: Fondazionefort)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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