Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
TRacKING
1 other identifier
observational
500
11 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 2, 2021
July 1, 2021
3.9 years
February 18, 2021
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Management of patient with actionable fusion
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
up to 48 months
Quality of life of patient
After 6, 12, 18, 24, 30, 36, 42, 48 months
- +8 more secondary outcomes
Interventions
* Data collection from the medical file * Quality of life questionnaire (QLQC30) at inclusion, at each change of treatment and then every 6 months
Eligibility Criteria
Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University Hospital Graz
Graz, Austria
Medical University of Vienna
Vienna, Austria
Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)
Brno, Czechia
Aarhus University Hospital
Aarhus, Denmark
Chu Jean Minjoz
Besançon, France
Institut Bergonie
Bordeaux, France
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, 59020, France
Chu Dupuytren
Limoges, France
Centre Léon Bérard
Lyon, 69008, France
Assistance Publique Hopitaux de Marseille (AP-HM)
Marseille, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, 75005, France
Aphp - Hopital de La Pitie Salpetriere
Paris, 75013, France
Aphp - Hopital Cohin
Paris, 75014, France
Aphp - Hopital Tenon
Paris, 75020, France
Centre Henri Becquerel
Rouen, France
Institut Claudius Regaud
Toulouse, France
"Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"
Aschaffenburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
"Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"
Chemnitz, Germany
"Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"
Frankfurt am Main, Germany
"Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"
Halle, Germany
"Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"
Magdeburg, 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
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
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
IRCCS Ospedale San Raffale
Milan, 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
Institute of Oncology of Ljubljana
Ljubljana, Slovenia
Complejo Hospitalario regional Virgen del Rocio
Seville, Spain
The Royal Marsden NHS Foundation Trust
London, United Kingdom
University College London NHS Foundation Trust
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Yves BLAY, Pr
Centre Leon Berard
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2021
First Posted
June 10, 2021
Study Start
June 22, 2021
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
August 2, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share