Clincosm LogoSign in Get a demo

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

Sponsor
Centre Leon Berard (Other)
Overall Status
Recruiting
CT.gov ID
NCT04921553
Collaborator
(none)
500
Enrollment
41
Locations
47.3
Anticipated Duration (Months)
12.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection and quality of life questionnaire

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).

  1. Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
Actual Study Start Date :
Jun 22, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Management of patient with actionable fusion [up to 48 months]

    Treatment scheme : number of line and type of treatments

  2. Time to relapse [up to 48 months]

  3. Progression Free Survival (PFS) [after 6, 12 and 24 months]

  4. Incidence of long-term responders [up to 48 months]

    long term responders =: > 24 months

  5. 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)

  6. Time to relapse for fusion-targeting treatments [up to 48 months]

  7. Overall survival for patient treated by fusion-targeting treatments [2 years]

  8. PFS for patient treated by fusion-targeting treatments [After 6, 12, 24 months of treatment by fusion targeting treatments]

    Progression free survival

  9. Incidence of long-term responders for patient treated by fusion-targeting treatments [up to 48 months]

    > 24 months

  10. 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)

  11. Safety : Nature of adverse reaction (for treatment targeting a fusion) [up to 48 months]

    Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

  12. Safety : Frequency of adverse reaction (for treatment targeting a fusion) [up to 48 months]

    Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

  13. Safety : Severity of adverse reaction (for treatment targeting a fusion) [up to 48 months]

    Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Graz Graz Austria
2 Medical University of Vienna Vienna Austria
3 Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav) Brno Czechia
4 Aarhus University Hospital Aarhus Denmark
5 Chu Jean Minjoz Besançon France
6 Institut Bergonie Bordeaux France
7 Centre Georges Francois Leclerc Dijon France
8 Centre Oscar Lambret Lille France 59020
9 Chu Dupuytren Limoges France
10 Centre Léon Bérard Lyon France 69008
11 Assistance Publique Hopitaux de Marseille (AP-HM) Marseille France
12 Centre Antoine Lacassagne Nice France
13 Institut Curie Paris France 75005
14 Aphp - Hopital de La Pitie Salpetriere Paris France 75013
15 Aphp - Hopital Cohin Paris France 75014
16 Aphp - Hopital Tenon Paris France 75020
17 Centre Henri Becquerel Rouen France
18 Institut Claudius Regaud Toulouse France
19 "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie" Aschaffenburg Germany
20 Charité - Universitätsmedizin Berlin Berlin Germany
21 "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz" Chemnitz Germany
22 "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt" Frankfurt am main Germany
23 "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle" Halle Germany
24 "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg" Magdeburg Germany
25 Mannheim University Medical Center (UniversitatsMedizin Mannheim) Mannheim Germany
26 "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München" München Germany
27 "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum" Nordhausen Germany
28 Universitätsklinikum Tübingen Medizinische Universitätsklinik; Tübingen Germany
29 University Hospital Würzburg (UniversitätsKlinikum Würzburg) Würzburg Germany
30 Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna Bologna Italy
31 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
32 Fondazione IRCCS Istituto Neurologico Carlo Besta Milano Italy
33 IRCCS Ospedale San Raffale Milano Italy
34 CRTR-AOU Federico II Napoli Italy
35 Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino Torino Italy
36 Leiden University Medical Center Leiden Netherlands
37 Maria Sklodowska Curie National Research Institute of Oncology Warsaw Poland
38 Institute of Oncology of Ljubljana Ljubljana Slovenia
39 Complejo Hospitalario regional Virgen del Rocio Sevilla Spain
40 The Royal Marsden NHS Foundation Trust London United Kingdom
41 University College London NHS Foundation Trust London United Kingdom

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

  • Principal Investigator: Jean-Yves BLAY, Pr, Centre Leon Berard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT04921553
Other Study ID Numbers:
  • ET20000258 TRacKING
First Posted:
Jun 10, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Leon Berard
actionnable fusion
cancer
registry
European reference network

Study Results

No Results Posted as of Aug 2, 2021