Trials / Unknown
UnknownNCT04921553
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Centre Leon Berard · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion. This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.
Detailed description
1. Administrative opening of the center 2. Routine identification of a patients harboring a rare actionable fusion 3. Patient's inclusion * Signature of written informed consent, * Declaration by the physician to the coordinating center (using the "Physician declaration" form) * Completion of the QLQ-C30 questionnaire (at inclusion, at each new treatment and then every 6 months). 4. Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.
Conditions
- Cancer
- Cancer Metastatic
- NTRK Gene Fusion Overexpression
- NTRK Family Gene Mutation
- ATIC-ALK Fusion Protein Expression
- ALK Fusion Protein Expression
- BCR-FGFR1 Fusion Protein Expression
- ROS1 Gene Translocation
- COL1A1-PDGFB Fusion Protein Expression
- RET Gene Translocation
- Gene Fusion
- ROS Gene Translocation
- BRAF Gene Rearrangement
- FGFR2 Gene Translocation
- FGFR3 Gene Translocation
- NTRK1 Gene Translocation
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Data collection and quality of life questionnaire | * Data collection from the medical file * Quality of life questionnaire (QLQC30) at inclusion, at each change of treatment and then every 6 months |
Timeline
- Start date
- 2021-06-22
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
- First posted
- 2021-06-10
- Last updated
- 2021-08-02
Locations
41 sites across 11 countries: Austria, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovenia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04921553. Inclusion in this directory is not an endorsement.