NTRK1/2/3 Fusion Gene Detection
Conditions
Keywords
NTRK
Brief summary
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.
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.
Interventions
None listed
Sponsors
Bayer
Federico Cappuzzo
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the incidence of NTRK rearrangements in patients with solid tumors in Italy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To define incidence of NTRK in different tumor types | 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 |
Countries
Italy
Outcome results
None listed