Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
- Conditions
- Cancer MetastaticCOL1A1-PDGFB Fusion Protein ExpressionNTRK Gene Fusion OverexpressionROS1 Gene TranslocationNTRK Family Gene MutationATIC-ALK Fusion Protein ExpressionALK Fusion Protein ExpressionROS Gene TranslocationBRAF Gene RearrangementNTRK1 Gene Translocation
- Registration Number
- NCT04921553
- Lead Sponsor
- Centre Leon Berard
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Incidence of long-term responders for patient treated by fusion-targeting treatments up to 48 months \> 24 months
Safety : Frequency of adverse reaction (for treatment targeting a fusion) up to 48 months Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Progression Free Survival (PFS) after 6, 12 and 24 months PFS for patient treated by fusion-targeting treatments After 6, 12, 24 months of treatment by fusion targeting treatments Progression free survival
Safety : Severity of adverse reaction (for treatment targeting a fusion) up to 48 months Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Time to relapse up to 48 months Time to relapse for fusion-targeting treatments up to 48 months Overall survival for patient treated by fusion-targeting treatments 2 years Safety : Nature of adverse reaction (for treatment targeting a fusion) up to 48 months Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Management of patient with actionable fusion up to 48 months Treatment scheme : number of line and type of treatments
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)
Trial Locations
- Locations (41)
University Hospital Graz
🇦🇹Graz, Austria
Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)
🇨🇿Brno, Czechia
Chu Jean Minjoz
🇫🇷Besançon, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
Institut Bergonie
🇫🇷Bordeaux, France
Chu Dupuytren
🇫🇷Limoges, France
Assistance Publique Hopitaux de Marseille (AP-HM)
🇫🇷Marseille, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Aphp - Hopital Cohin
🇫🇷Paris, France
Aphp - Hopital Tenon
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
"Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"
🇩🇪Aschaffenburg, Germany
"Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"
🇩🇪Chemnitz, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
"Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"
🇩🇪Frankfurt am main, Germany
"Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"
🇩🇪Magdeburg, Germany
"Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"
🇩🇪Halle, Germany
Mannheim University Medical Center (UniversitatsMedizin Mannheim)
🇩🇪Mannheim, Germany
"Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"
🇩🇪München, Germany
"Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"
🇩🇪Nordhausen, Germany
Universitätsklinikum Tübingen Medizinische Universitätsklinik;
🇩🇪Tübingen, Germany
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
University Hospital Würzburg (UniversitätsKlinikum Würzburg)
🇩🇪Würzburg, Germany
Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna
🇮🇹Bologna, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
IRCCS Ospedale San Raffale
🇮🇹Milano, Italy
CRTR-AOU Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Maria Sklodowska Curie National Research Institute of Oncology
🇵🇱Warsaw, Poland
Complejo Hospitalario regional Virgen del Rocio
🇪🇸Sevilla, Spain
Institute of Oncology of Ljubljana
🇸🇮Ljubljana, Slovenia
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
University College London NHS Foundation Trust
🇬🇧London, United Kingdom
Medical University of Vienna
🇦🇹Vienna, Austria
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Centre Oscar Lambret
🇫🇷Lille, France
Institut Curie
🇫🇷Paris, France
Aphp - Hopital de La Pitie Salpetriere
🇫🇷Paris, France