Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion

NCT ID: NCT04557813

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2024-12-31

Brief Summary

The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3

Detailed Description

The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2 or NTRK3 gene fusions, thereby generating real world evidence. It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK (Neurotrophic Tyrosine Receptor Kinase) fusion-positive cancer. All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer, irrespective of the type of antineoplastic treatment, will be documented. Data will be assessed at least 36 months per patient (i.e. until 36 months after inclusion of the last patient in the study). This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses. Intra-individual and inter-individual comparisons (for the latter, provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor) could be performed.

The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations.

Conditions

NTRK Family Gene Mutation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

IC before start of any treatment

Informed consent (IC) before start of any treatment after diagnosis of NTRK fusion-positive cancer. All data after diagnosis of NTRK fusion-positive cancer are collected prospectively.

No interventions assigned to this group

IC after start of any treatment

IC after start of any treatment after diagnosis of NTRK fusion-positive cancer. Data after study inclusion are collected prospectively and retrospectively.

No interventions assigned to this group

Deceased patients

Patients deceased prior to study inclusion (no IC required). All data are collected retrospectively.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Locally advanced or metastatic solid tumor with a documented NTRK gene fusion, based on a validated assay (according to current ESMO recommendations), or the provision of tumor material for central retesting
• Molecular pathology or molecular diagnostics report with details on NTRK gene fusion testing must be available
• Aged ≥ 18 years
• Signed and dated informed consent form (ICF) (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

Exclusion Criteria

• Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland)
• Participation in a clinical trial with a TRK inhibitor before or at enrolment (liv-ing patients) or before inclusion (deceased patients)
• Deceased patients who have explicitly contradicted further use of data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Kasenda, PD Dr. Dr.

Role: STUDY_DIRECTOR

Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

Locations

Universitätsklinikum Augsburg

Augsburg, , Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, , Germany

Gesundheit Nord, Klinikverbund Bremen

Bremen, , Germany

PIOH - Praxis Internistische Onkologie und Hämatologie

Cologne, , Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, , Germany

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Onkologische Schwerpunktpraxis

Hanover, , Germany

Gemeinschaftspraxis

Hanover, , Germany

SLK Kliniken Heilbronn Klinik für Innere Medizin III

Heilbronn, , Germany

Klinikum Kempten

Kempten, , Germany

Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie

Landsberg, , Germany

Onkologische Praxis am Marien-Krankenhaus

Lübeck, , Germany

Praxis für Onkologie

Mönchengladbach, , Germany

Klinikum rechts der Isar der TUM Innere Medizin II

München, , Germany

Universitätsklinikum Münster, Medizinische Klinik A

Münster, , Germany

TZN - Tumorzentrum Niederrhein GmbH

Neuss, , Germany

Studienzentrum Onkologie Ravensburg

Ravensburg, , Germany

Praxis und Tagesklinik für Onkologie und Hämatologie

Recklinghausen, , Germany

Klinikum Rosenheim

Rosenheim, , Germany

Zentrum Ambulante Onkologie

Schorndorf, , Germany

MVZ Kloster Paradiese GbR

Soest, , Germany

MVZ für Hämatologie und Onkologie

Ulm, , Germany

Onkologie Schwarzwald-Alb

Villingen-Schwenningen, , Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, , Germany

Universitätsspital Basel

Basel, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

IOM-040444

Identifier Type: -

Identifier Source: org_study_id