ALK Fusion Protein Expression, ATIC-ALK Fusion Protein Expression, BCR-FGFR1 Fusion Protein Expression, BRAF Gene Rearrangement, Cancer, Cancer Metastatic, COL1A1-PDGFB Fusion Protein Expression, FGFR2 Gene Translocation, FGFR3 Gene Translocation, Gene Fusion, NTRK1 Gene Translocation, NTRK Family Gene Mutation, NTRK Gene Fusion Overexpression, RET Gene Translocation, ROS1 Gene Translocation, ROS Gene Translocation
Conditions
Keywords
actionnable fusion, cancer, registry, European reference network
Brief 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.
Interventions
OTHERData 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
Sponsors
Centre Leon Berard
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | To describe the survival rate of patients with solid cancers harboring a NTRK fusion or other rare actionable fusion in real-life practice, according to overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse | up to 48 months | — |
| Progression Free Survival (PFS) | after 6, 12 and 24 months | — |
| Incidence of long-term responders | up to 48 months | long term responders =: \> 24 months |
| Quality of life of patient | After 6, 12, 18, 24, 30, 36, 42, 48 months | To evaluate patient-reported outcomes concerning individual QoL according to QLQ-C30 (EORTC Quality of Life questionnaires) |
| Time to relapse for fusion-targeting treatments | up to 48 months | — |
| Overall survival for patient treated by fusion-targeting treatments | 2 years | — |
| Management of patient with actionable fusion | up to 48 months | Treatment scheme : number of line and type of treatments |
| Incidence of long-term responders for patient treated by fusion-targeting treatments | up to 48 months | \> 24 months |
| Quality of life of patient treated by fusion-targeting treatments | After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments | using QLQC30 (EORTC Quality of Life questionnaires) |
| Safety : Nature of adverse reaction (for treatment targeting a fusion) | up to 48 months | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. |
| Safety : Frequency of adverse reaction (for treatment targeting a fusion) | up to 48 months | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. |
| Safety : Severity of adverse reaction (for treatment targeting a fusion) | up to 48 months | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. |
| PFS for patient treated by fusion-targeting treatments | After 6, 12, 24 months of treatment by fusion targeting treatments | Progression free survival |
Countries
Austria, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovenia, Spain, United Kingdom
Contacts
Primary ContactJulien Bollard
Backup ContactAlexandra BIETTE
Outcome results
None listed