NTRK Family Gene MutationREALTRKNCT04557813
Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion
An observational study of NTRK Family Gene Mutation, run by iOMEDICO AG at 26 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NTRK Family Gene Mutation
- How many people
- 88 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 2 Dec 2020to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with advanced (locally advanced or metastatic) solid tumors harboring a NTRK1, NTRK2 or NTRK3 gene fusion
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
Germany25 sites
Universitätsklinikum Augsburg
Augsburg
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707
Gesundheit Nord, Klinikverbund Bremen
Bremen
PIOH - Praxis Internistische Onkologie und Hämatologie
Cologne, 50674
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, 60389
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, 79110
Asklepios Klinik Altona
Hamburg, 22763
Onkologische Schwerpunktpraxis
Hanover, 30161
Gemeinschaftspraxis
Hanover, 30625
SLK Kliniken Heilbronn Klinik für Innere Medizin III
Heilbronn, 74078
Klinikum Kempten
Kempten, 87439
Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie
Landsberg, 86899
Onkologische Praxis am Marien-Krankenhaus
Lübeck, 23552
Praxis für Onkologie
Mönchengladbach, 41066
Klinikum rechts der Isar der TUM Innere Medizin II
München, 81675
Universitätsklinikum Münster, Medizinische Klinik A
Münster, 48149
TZN - Tumorzentrum Niederrhein GmbH
Neuss, 41462
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212
Praxis und Tagesklinik für Onkologie und Hämatologie
Recklinghausen, 45659
Klinikum Rosenheim
Rosenheim, 83022
Zentrum Ambulante Onkologie
Schorndorf, 73614
MVZ Kloster Paradiese GbR
Soest, 59494
MVZ für Hämatologie und Onkologie
Ulm, 89073
Onkologie Schwarzwald-Alb
Villingen-Schwenningen, 78052
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden
About this study
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
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
Read the 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
- Keywords
- NTRK, NTRK-fusion, Neurotrophic Tyrosine Receptor Kinase, NTRK Gene Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Proportion of patients with CR or PR as best response
Measured: through study completion, at least 1 year
Secondary outcomes (14)
Patient and disease characteristics
Descriptive summary of demographics, patient and disease characteristics
Measured: through study completion, at least 1 year
Test methods used for diagnosis of a NTRK fusion-positive cancer
Description of test methods used for diagnosis of a NTRK fusion-positive cancer and results thereof
Measured: Day 1
Physician-reported factors affecting decision to test for NTRK fusion and treatment decision
Description of physician-reported factors affecting decision to test for NTRK fusion and treatment decision making after diagnosis of NTRK gene fusion
Measured: Day 1
Treatment reality after diagnosis of NTRK gene fusion
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.
Measured: through study completion, at least 1 year
Safety of TRK inhibitor treatments
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.
Measured: through study completion, at least 1 year
Physician-reported evaluation of TRK inhibitor therapy
Description of physician-reported evaluation of TRK inhibitor therapy
Measured: Day 1
Disease-related symptoms
Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I)
Measured: through study completion, at least 1 year
Disease control rate
Proportion of patients with CR, PR or SD as best response
Measured: through study completion, at least 1 year
Time to Response
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
Measured: through study completion, at least 1 year
Duration of Response
Time from documentation of tumor response to disease progression or death from any cause
Measured: through study completion, at least 1 year
Progression-free survival
Time from start of treatment until disease progression or death
Measured: through study completion, at least 1 year
Overall Survival
Time from start of treatment until death of any cause
Measured: through study completion, at least average of 1 year
PFS ratio
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
Measured: through study completion, at least 1 year
Event-free survival
Time from start of treatment until PD or death
Measured: through study completion, at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start2 Dec 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NTRK Family Gene MutationStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 88 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Benjamin Kasenda, PD Dr. Dr., Study director, Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557813
- Sponsor's protocol ID
- IOM-040444
- Acronym
- REALTRK
- Status last verified
- Mar 2025
- First submitted
- 2 Sep 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04557813
- Acronym / sponsor ID
- REALTRK / IOM-040444
- Conditions
- NTRK Family Gene Mutation
- Keywords
- NTRK, NTRK-fusion, Neurotrophic Tyrosine Receptor Kinase, NTRK Gene Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with advanced (locally advanced or metastatic) solid tumors harboring a NTRK1, NTRK2 or NTRK3 gene fusion
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall response rate
Time frame: through study completion, at least 1 year
Proportion of patients with CR or PR as best response
14 secondary outcomes
Patient and disease characteristics
Time frame: through study completion, at least 1 year
Test methods used for diagnosis of a NTRK fusion-positive cancer
Time frame: Day 1
Physician-reported factors affecting decision to test for NTRK fusion and treatment decision
Time frame: Day 1
Treatment reality after diagnosis of NTRK gene fusion
Time frame: through study completion, at least 1 year
Safety of TRK inhibitor treatments
Time frame: through study completion, at least 1 year
Physician-reported evaluation of TRK inhibitor therapy
Time frame: Day 1
Disease-related symptoms
Time frame: through study completion, at least 1 year
Disease control rate
Time frame: through study completion, at least 1 year
Time to Response
Time frame: through study completion, at least 1 year
Duration of Response
Time frame: through study completion, at least 1 year
Progression-free survival
Time frame: through study completion, at least 1 year
Overall Survival
Time frame: through study completion, at least average of 1 year
PFS ratio
Time frame: through study completion, at least 1 year
Event-free survival
Time frame: through study completion, at least 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Kasenda, PD Dr. Dr. study director
Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NTRK Family Gene Mutation, run by iOMEDICO AG at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: through study completion, at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.