Clinical trial · Observational
A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study
A Study to Determine the Incidence of NTRK Fusions in Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors With NTRK Fusions and Related Treatment Outcomes.
NCT04010240CI-TRIAL-00096626NTRKcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (this is a retrospective cohort study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors
- interventionNames
- Other: No intervention (this is a retrospective cohort study)
Primary outcomes (1)
- measure
- Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing).
- timeFrame
- at baseline (i.e. at the time of tumor removal)
- description
- A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on NGS (Next-generation sequencing methods). NGS (Next-generation sequencing methods) method: DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay as previously described.
Secondary outcomes (1)
- measure
- Count of Participants With NRTK Fusions Among Participants With With Positive Immunohistochemistry (IHC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.