Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)

Léon Bérard Center

Status: Enrolling

Conditions: BCR-FGFR1 Fusion Protein Expression; ATIC-ALK Fusion Protein Expression; FGFR2 Gene Translocation; COL1A1-PDGFB Fusion Protein Expression; FGFR3 Gene Translocation; ROS Gene Translocation; ALK Fusion Protein Expression; Cancer; Cancer Metastatic; NTRK Family Gene Mutation; NTRK Gene Fusion Overexpression; ROS1 Gene Translocation; NTRK1 Gene Translocation; BRAF Gene Rearrangement; RET Gene Translocation; Gene Fusion

Treatments: Other: Data collection and quality of life questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04921553

ET20000258 TRacKING

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with histologically-confirmed cancer
• Patient harboring a rare actionable fusion (see Appendix 1),
• Availability of clinical and demographic data, information on treatment and clinical outcome.
• Adult, ≥18 years old,
• Patient should understand, sign and date the written voluntary informed consent form.

Exclusion criteria