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

Completed

• 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.

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Study Start: 2020-12-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate	through study completion, at least 1 year	Proportion of patients with CR or PR as best response

Secondary Outcome Measures

Name	Time	Method
PFS ratio	through study completion, at least 1 year	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
Patient and disease characteristics	through study completion, at least 1 year	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
Disease control rate	through study completion, at least 1 year	Proportion of patients with CR, PR or SD as best response
Overall Survival	through study completion, at least average of 1 year	Time from start of treatment until death of any cause
Event-free survival	through study completion, at least 1 year	Time from start of treatment until PD or death
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
Treatment reality after diagnosis of NTRK gene fusion	through study completion, at least 1 year	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	through study completion, at least 1 year	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.
Physician-reported evaluation of TRK inhibitor therapy	Day 1	Description of physician-reported evaluation of TRK inhibitor therapy
Disease-related symptoms	through study completion, at least 1 year	Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I)
Time to Response	through study completion, at least 1 year	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
Duration of Response	through study completion, at least 1 year	Time from documentation of tumor response to disease progression or death from any cause
Progression-free survival	through study completion, at least 1 year	Time from start of treatment until disease progression or death

Trial Locations

Locations (26)

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Gesundheit Nord, Klinikverbund Bremen; 🇩🇪 Bremen, Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden; 🇩🇪 Wiesbaden, Germany

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

SLK Kliniken Heilbronn Klinik für Innere Medizin III; 🇩🇪 Heilbronn, Germany

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