Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion
- Conditions
- NTRK Family Gene Mutation
- Registration Number
- NCT04557813
- Lead Sponsor
- iOMEDICO AG
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 88
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate 36 months Proportion of patients with CR or PR as best response
- Secondary Outcome Measures
Name Time Method Physician-reported factors affecting decision to test for NTRK fusion and treatment decision Day 1 Description of physician-reported factors affecting decision to test for NTRK fusion and treatment decision making after diagnosis of NTRK gene fusion
Disease-related symptoms 36 months Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I)
Event-free survival 36 months Time from start of treatment until PD or death
Patient and disease characteristics 36 months Descriptive summary of demographics, patient and disease characteristics
Test methods used for diagnosis of a NTRK fusion-positive cancer Day 1 Description of test methods used for diagnosis of a NTRK fusion-positive cancer and results thereof
Treatment reality after diagnosis of NTRK gene fusion 36 months Description of all treatment lines given to the patient after diagnosis of NTRK gene fusion including: Type of treatment (Systemic TRK inhibitor treatments or Non-TRK inhibitor treatments), treatment duration, dosing, treatment modifications and reasons thereof, reasons for end of treatment.
Safety of TRK inhibitor treatments 36 months Treatment-emergent AEs (i.e., AEs which occurred during a specific TRK inhibitor treatment and in the respective survival FU) will be calculated per patient (absolute and relative frequencies) and case-based (absolute frequencies). The occurrence of any (S)AE will be displayed overall and per CTCAE grade. Adverse drug reactions (ADRs) and AESIs will be displayed accordingly.
Incidence of AEs (MedDRA Preferred Term (PT) by System Organ Class (SOC)) will be calculated accordingly for each type of AE/ADR.Disease control rate 36 months Proportion of patients with CR, PR or SD as best response
Progression-free survival 36 months Time from start of treatment until disease progression or death
Duration of Response 36 months Time from documentation of tumor response to disease progression or death from any cause
Physician-reported evaluation of TRK inhibitor therapy Day 1 Description of physician-reported evaluation of TRK inhibitor therapy
Overall Survival 36 months Time from start of treatment until death of any cause
PFS ratio 36 months ratio of PFS of the first treatment line with a TRK inhibitor to time to progression (TTP) in the preceding treatment line without a TRK inhibitor
Time to Response 36 months Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR
Trial Locations
- Locations (23)
Onkologische Schwerpunktpraxis Kurfürstendamm
🇩🇪Berlin, Germany
Centrum für Hämatologie und Onkologie Bethanien
🇩🇪Frankfurt, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie
🇩🇪Freiburg, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Onkologische Schwerpunktpraxis
🇩🇪Hannover, Germany
Gemeinschaftspraxis
🇩🇪Hannover, Germany
Klinikum Kempten
🇩🇪Kempten, Germany
SLK Kliniken Heilbronn Klinik für Innere Medizin III
🇩🇪Heilbronn, Germany
PIOH - Praxis Internistische Onkologie und Hämatologie
🇩🇪Köln, Germany
Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie
🇩🇪Landsberg, Germany
Onkologische Praxis am Marien-Krankenhaus
🇩🇪Lübeck, Germany
Klinikum rechts der Isar der TUM Innere Medizin II
🇩🇪München, Germany
Praxis für Onkologie
🇩🇪Mönchengladbach, Germany
TZN - Tumorzentrum Niederrhein GmbH
🇩🇪Neuss, Germany
Universitätsklinikum Münster, Medizinische Klinik A
🇩🇪Münster, Germany
Studienzentrum Onkologie Ravensburg
🇩🇪Ravensburg, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
🇩🇪Recklinghausen, Germany
Klinikum Rosenheim
🇩🇪Rosenheim, Germany
MVZ für Hämatologie und Onkologie
🇩🇪Ulm, Germany
MVZ Kloster Paradiese GbR
🇩🇪Soest, Germany
Zentrum Ambulante Onkologie
🇩🇪Schorndorf, Germany
Onkologie Schwarzwald-Alb
🇩🇪Villingen-Schwenningen, Germany
Universitätsspital Basel
🇨🇭Basel, Switzerland