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

NCT04557813 | Completed

• 1 other identifier: IOM-040444
• Study Type: observational
• Target: 88
• Locations: 2 countries
• Sites: 26

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

Conditions

NTRK Family Gene Mutation

Keywords

NTRK; NTRK-fusion; Neurotrophic Tyrosine Receptor Kinase; NTRK Gene Fusion

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Proportion of patients with CR or PR as best response

  through study completion, at least 1 year

Secondary Outcomes (14)

• Patient and disease characteristics

  through study completion, at least 1 year

• Test methods used for diagnosis of a NTRK fusion-positive cancer

  Day 1

• Physician-reported factors affecting decision to test for NTRK fusion and treatment decision

  Day 1

• Treatment reality after diagnosis of NTRK gene fusion

  through study completion, at least 1 year

• Safety of TRK inhibitor treatments

  through study completion, at least 1 year

Study Arms (3)

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.

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.

Deceased patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with advanced (locally advanced or metastatic) solid tumors harboring a NTRK1, NTRK2 or NTRK3 gene fusion

You may qualify if:

• 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

You may not qualify if:

• Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland)
• Deceased patients who have explicitly contradicted further use of data

Sponsors & Collaborators

• iOMEDICO AG: lead
• Roche Pharma AG: collaborator

Study Sites (26)

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Location

Gesundheit Nord, Klinikverbund Bremen

Bremen, Germany

Location

PIOH - Praxis Internistische Onkologie und Hämatologie

Cologne, 50674, Germany

Location

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, 60389, Germany

Location

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, 79110, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Onkologische Schwerpunktpraxis

Hanover, 30161, Germany

Location

Gemeinschaftspraxis

Hanover, 30625, Germany

Location

SLK Kliniken Heilbronn Klinik für Innere Medizin III

Heilbronn, 74078, Germany

Location

Klinikum Kempten

Kempten, 87439, Germany

Location

Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie

Landsberg, 86899, Germany

Location

Onkologische Praxis am Marien-Krankenhaus

Lübeck, 23552, Germany

Location

Praxis für Onkologie

Mönchengladbach, 41066, Germany

Location

Klinikum rechts der Isar der TUM Innere Medizin II

München, 81675, Germany

Location

Universitätsklinikum Münster, Medizinische Klinik A

Münster, 48149, Germany

Location

TZN - Tumorzentrum Niederrhein GmbH

Neuss, 41462, Germany

Location

Studienzentrum Onkologie Ravensburg

Ravensburg, 88212, Germany

Location

Praxis und Tagesklinik für Onkologie und Hämatologie

Recklinghausen, 45659, Germany

Location

Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Zentrum Ambulante Onkologie

Schorndorf, 73614, Germany

Location

MVZ Kloster Paradiese GbR

Soest, 59494, Germany

Location

MVZ für Hämatologie und Onkologie

Ulm, 89073, Germany

Location

Onkologie Schwarzwald-Alb

Villingen-Schwenningen, 78052, Germany

Location

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, Germany

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Study Officials

• Benjamin Kasenda, PD Dr. Dr.

  Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 22, 2020
• Study Start: December 2, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (25)