N/A
N=3,820
A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study
Metastatic Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT04010240 ↗Enrolled (actual)
3,820
Serious AEs
—
Results posted
Oct 2025
Primary outcome: Primary: Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing). — 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (this is a retrospective cohort study) (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing). |
11 | — |
| SECONDARY Count of Participants With NRTK Fusions Among Participants With With Positive Immunohistochemistry (IHC) |
1 | — |
Summary
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 1 month.
- Subject has/had a histologically or cytologically confirmed diagnosis of solid tumor including but not exclusively: soft tissue sarcoma, BRAF wild type melanoma, KRAS wild-type colorectal cancer, central nervous system, EGFR-wild type non-small cell lung cancer.
- Subject has locally advanced/unresectable or metastatic disease.
- Subject has received at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic disease for which there is available outcome information in terms of PFS, or the latter can be estimated based on the subject's records.
- Subject has tumor material available for immunoscreening (IHC for NTRK gene fusions).
- Written and voluntary informed consent understood, signed and dated, or a waiver of consent is granted according to French régulations.
Exclusion Criteria
- Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.
Data sourced from ClinicalTrials.gov (NCT04010240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.