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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.
Administrative opening of the center
Routine identification of a patients harboring a rare actionable fusion
Patient's inclusion
Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection and quality of life questionnaire | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien Bollard | Contact | 04 78 78 28 28 | julien.bollard@lyon.unicancer.fr | |
| Alexandra BIETTE | Contact | 04 78 78 28 28 | alexandra.biette@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves BLAY, Pr | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Graz | Not yet recruiting | Graz | Austria |
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| 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 |
| Medical University of Vienna | Not yet recruiting | Vienna | Austria |
|
| Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav) | Not yet recruiting | Brno | Czechia |
|
| Aarhus University Hospital | Not yet recruiting | Aarhus | Denmark |
|
| Chu Jean Minjoz | Not yet recruiting | Besançon | France |
|
| Institut Bergonie | Recruiting | Bordeaux | France |
|
| Centre Georges Francois Leclerc | Not yet recruiting | Dijon | France |
|
| Centre Oscar Lambret | Not yet recruiting | Lille | 59020 | France |
|
| Chu Dupuytren | Not yet recruiting | Limoges | France |
|
| Centre Léon Bérard | Recruiting | Lyon | 69008 | France |
|
| Assistance Publique Hopitaux de Marseille (AP-HM) | Not yet recruiting | Marseille | France |
|
| Centre Antoine Lacassagne | Not yet recruiting | Nice | France |
|
| Institut Curie | Not yet recruiting | Paris | 75005 | France |
|
| Aphp - Hopital de La Pitie Salpetriere | Not yet recruiting | Paris | 75013 | France |
|
| Aphp - Hopital Cohin | Not yet recruiting | Paris | 75014 | France |
|
| Aphp - Hopital Tenon | Not yet recruiting | Paris | 75020 | France |
|
| Centre Henri Becquerel | Not yet recruiting | Rouen | France |
|
| Institut Claudius Regaud | Not yet recruiting | Toulouse | France |
|
| "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie" | Not yet recruiting | Aschaffenburg | Germany |
|
| Charité - Universitätsmedizin Berlin | Not yet recruiting | Berlin | Germany |
|
| "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz" | Not yet recruiting | Chemnitz | Germany |
|
| "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt" | Not yet recruiting | Frankfurt am Main | Germany |
|
| "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle" | Not yet recruiting | Halle | Germany |
|
| "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg" | Not yet recruiting | Magdeburg | Germany |
|
| Mannheim University Medical Center (UniversitatsMedizin Mannheim) | Not yet recruiting | Mannheim | Germany |
|
| "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München" | Not yet recruiting | München | Germany |
|
| "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum" | Not yet recruiting | Nordhausen | Germany |
|
| Universitätsklinikum Tübingen Medizinische Universitätsklinik; | Not yet recruiting | Tübingen | Germany |
|
| University Hospital Würzburg (UniversitätsKlinikum Würzburg) | Not yet recruiting | Würzburg | Germany |
|
| Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna | Not yet recruiting | Bologna | Italy |
|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Not yet recruiting | Meldola | Italy |
|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Not yet recruiting | Milan | Italy |
|
| IRCCS Ospedale San Raffale | Not yet recruiting | Milan | Italy |
|
| CRTR-AOU Federico II | Not yet recruiting | Naples | Italy |
|
| Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino | Not yet recruiting | Torino | Italy |
|
| Leiden University Medical Center | Not yet recruiting | Leiden | Netherlands |
|
| Maria Sklodowska Curie National Research Institute of Oncology | Not yet recruiting | Warsaw | Poland |
|
| Institute of Oncology of Ljubljana | Not yet recruiting | Ljubljana | Slovenia |
|
| Complejo Hospitalario regional Virgen del Rocio | Not yet recruiting | Seville | Spain |
|
| The Royal Marsden NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| University College London NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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