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

Study Overview
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Brief Summary
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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
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Administrative opening of the center Routine identification of a patients harboring a rare actionable fusion 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). Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.

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

Conditions
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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

Intervention / Treatment
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* Other: Data collection and quality of life questionnaire


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of patient with actionable fusion | Treatment scheme : number of line and type of treatments | up to 48 months | 
| Time to relapse |  | up to 48 months | 
| Progression Free Survival (PFS) |  | after 6, 12 and 24 months | 
| Incidence of long-term responders | long term responders =: > 24 months | up to 48 months | 
| Quality of life of patient | To evaluate patient-reported outcomes concerning individual QoL according to QLQ-C30 (EORTC Quality of Life questionnaires) | After 6, 12, 18, 24, 30, 36, 42, 48 months | 
| Time to relapse for fusion-targeting treatments |  | up to 48 months | 
| Overall survival for patient treated by fusion-targeting treatments |  | 2 years | 
| PFS for patient treated by fusion-targeting treatments | Progression free survival | After 6, 12, 24 months of treatment by fusion targeting treatments | 
| Incidence of long-term responders for patient treated by fusion-targeting treatments | > 24 months | up to 48 months | 
| Quality of life of patient treated by fusion-targeting treatments | using QLQC30 (EORTC Quality of Life questionnaires) | After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments | 
| Safety : Nature of adverse reaction (for treatment targeting a fusion) | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. | up to 48 months | 
| Safety : Frequency of adverse reaction (for treatment targeting a fusion) | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. | up to 48 months | 
| Safety : Severity of adverse reaction (for treatment targeting a fusion) | Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. | up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actionnable fusion, cancer, registry, European reference network