Clinical trial NCT04557813: Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion
Official title: Registry for Molecular Testing, Treatment and Outcome of Patients With Locally Advanced or Metastatic Solid Tumors Harboring a Fusion of NTRK1, NTRK2 or NTRK3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NTRK Family Gene Mutation
Keywords: NTRK
NTRK-fusion
Neurotrophic Tyrosine Receptor Kinase
NTRK Gene Fusion
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2020-09-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with advanced (locally advanced or metastatic) solid tumors harboring a NTRK1, NTRK2 or NTRK3 gene fusion

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.

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

Primary outcomes:
measure: Overall response rate
timeFrame: through study completion, at least 1 year
Secondary outcomes:
measure: Patient and disease characteristics
timeFrame: through study completion, at least 1 year
measure: Test methods used for diagnosis of a NTRK fusion-positive cancer
timeFrame: Day 1
measure: Physician-reported factors affecting decision to test for NTRK fusion and treatment decision
timeFrame: Day 1
measure: Treatment reality after diagnosis of NTRK gene fusion
timeFrame: through study completion, at least 1 year
measure: Safety of TRK inhibitor treatments
timeFrame: through study completion, at least 1 year
measure: Physician-reported evaluation of TRK inhibitor therapy
timeFrame: Day 1
measure: Disease-related symptoms
timeFrame: through study completion, at least 1 year
measure: Disease control rate
timeFrame: through study completion, at least 1 year
measure: Time to Response
timeFrame: through study completion, at least 1 year
measure: Duration of Response
timeFrame: through study completion, at least 1 year
measure: Progression-free survival
timeFrame: through study completion, at least 1 year
measure: Overall Survival
timeFrame: through study completion, at least average of 1 year
measure: PFS ratio
timeFrame: through study completion, at least 1 year
measure: Event-free survival
timeFrame: through study completion, at least 1 year
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Bremen
country: Germany
facility: Gesundheit Nord, Klinikverbund Bremen
city: Frankfurt
country: Germany
facility: Centrum für Hämatologie und Onkologie Bethanien
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Hannover
country: Germany
facility: Gemeinschaftspraxis
city: Heilbronn
country: Germany
facility: SLK Kliniken Heilbronn Klinik für Innere Medizin III
city: Kempten
country: Germany
facility: Klinikum Kempten
city: Köln
country: Germany
facility: PIOH - Praxis Internistische Onkologie und Hämatologie
city: Landsberg
country: Germany
facility: Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie
city: Lübeck
country: Germany
facility: Onkologische Praxis am Marien-Krankenhaus
city: Mönchengladbach
country: Germany
facility: Praxis für Onkologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TUM Innere Medizin II
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Medizinische Klinik A
city: Neuss
country: Germany
facility: TZN - Tumorzentrum Niederrhein GmbH
city: Ravensburg
country: Germany
facility: Studienzentrum Onkologie Ravensburg
city: Recklinghausen
country: Germany
facility: Praxis und Tagesklinik für Onkologie und Hämatologie
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Schorndorf
country: Germany
facility: Zentrum Ambulante Onkologie
city: Soest
country: Germany
facility: MVZ Kloster Paradiese GbR
city: Ulm
country: Germany
facility: MVZ für Hämatologie und Onkologie
city: Villingen-Schwenningen
country: Germany
facility: Onkologie Schwarzwald-Alb
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
name: Benjamin Kasenda, PD Dr. Dr.
role: STUDY_DIRECTOR
References: