Clinical trial NCT04921553: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
Official title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: actionnable fusion
cancer
registry
European reference network
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Management of patient with actionable fusion
timeFrame: up to 48 months
measure: Time to relapse
timeFrame: up to 48 months
measure: Progression Free Survival (PFS)
timeFrame: after 6, 12 and 24 months
measure: Incidence of long-term responders
timeFrame: up to 48 months
measure: Quality of life of patient
timeFrame: After 6, 12, 18, 24, 30, 36, 42, 48 months
measure: Time to relapse for fusion-targeting treatments
timeFrame: up to 48 months
measure: Overall survival for patient treated by fusion-targeting treatments
timeFrame: 2 years
measure: PFS for patient treated by fusion-targeting treatments
timeFrame: After 6, 12, 24 months of treatment by fusion targeting treatments
measure: Incidence of long-term responders for patient treated by fusion-targeting treatments
timeFrame: up to 48 months
measure: Quality of life of patient treated by fusion-targeting treatments
timeFrame: After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments
measure: Safety : Nature of adverse reaction (for treatment targeting a fusion)
timeFrame: up to 48 months
measure: Safety : Frequency of adverse reaction (for treatment targeting a fusion)
timeFrame: up to 48 months
measure: Safety : Severity of adverse reaction (for treatment targeting a fusion)
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Hospital Graz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Besançon
country: France
facility: Chu Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Chu Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille (AP-HM)
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Aphp - Hopital de La Pitie Salpetriere
city: Paris
country: France
facility: Aphp - Hopital Cohin
city: Paris
country: France
facility: Aphp - Hopital Tenon
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Aschaffenburg
country: Germany
facility: "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Chemnitz
country: Germany
facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"
city: Frankfurt am main
country: Germany
facility: "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"
city: Halle
country: Germany
facility: "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"
city: Magdeburg
country: Germany
facility: "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"
city: Mannheim
country: Germany
facility: Mannheim University Medical Center (UniversitatsMedizin Mannheim)
city: München
country: Germany
facility: "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"
city: Nordhausen
country: Germany
facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Medizinische Universitätsklinik;
city: Würzburg
country: Germany
facility: University Hospital Würzburg (UniversitätsKlinikum Würzburg)
city: Bologna
country: Italy
facility: Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffale
city: Napoli
country: Italy
facility: CRTR-AOU Federico II
city: Torino
country: Italy
facility: Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Warsaw
country: Poland
facility: Maria Sklodowska Curie National Research Institute of Oncology
city: Ljubljana
country: Slovenia
facility: Institute of Oncology of Ljubljana
city: Sevilla
country: Spain
facility: Complejo Hospitalario regional Virgen del Rocio
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
Study officials:
affiliation: Centre Leon Berard
name: Jean-Yves BLAY, Pr
role: PRINCIPAL_INVESTIGATOR
References: