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

Cancer Clinical Trial

— TRacKING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921553
• Other study ID #: ET20000258 TRacKING
• Status: Recruiting
• Start date: June 22, 2021
• Est. completion date: June 2025

Study information

• Verified date: July 2021
• Source: Centre Leon Berard
• Contact: Julien Bollard
• Phone: 04 78 78 28 28
• Email: julien.bollard[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• ALK Fusion Protein Expression
• Cancer
• Cancer Metastatic
• FGFR2 Gene Translocation
• FGFR3 Gene Translocation
• Gene Fusion
• NTRK Family Gene Mutation
• ROS1 Gene Translocation

Intervention

Other:
• Data collection and quality of life questionnaire
Data collection from the medical file Quality of life questionnaire (QLQC30) at inclusion, at each change of treatment and then every 6 months

Locations

Country	Name	City	State
Austria	University Hospital Graz	Graz
Austria	Medical University of Vienna	Vienna
Czechia	Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)	Brno
Denmark	Aarhus University Hospital	Aarhus
France	Chu Jean Minjoz	Besançon
France	Institut Bergonie	Bordeaux
France	Centre Georges Francois Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Chu Dupuytren	Limoges
France	Centre Léon Bérard	Lyon
France	Assistance Publique Hopitaux de Marseille (AP-HM)	Marseille
France	Centre Antoine Lacassagne	Nice
France	Aphp - Hopital Cohin	Paris
France	Aphp - Hopital de La Pitie Salpetriere	Paris
France	Aphp - Hopital Tenon	Paris
France	Institut Curie	Paris
France	Centre Henri Becquerel	Rouen
France	Institut Claudius Regaud	Toulouse
Germany	"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
Italy	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	Milano
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
Netherlands	Leiden University Medical Center	Leiden
Poland	Maria Sklodowska Curie National Research Institute of Oncology	Warsaw
Slovenia	Institute of Oncology of Ljubljana	Ljubljana
Spain	Complejo Hospitalario regional Virgen del Rocio	Sevilla
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Countries where clinical trial is conducted

Austria,  Czechia,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Slovenia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Management of patient with actionable fusion	Treatment scheme : number of line and type of treatments	up to 48 months
Secondary	Time to relapse		up to 48 months
Secondary	Progression Free Survival (PFS)		after 6, 12 and 24 months
Secondary	Incidence of long-term responders	long term responders =: > 24 months	up to 48 months
Secondary	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
Secondary	Time to relapse for fusion-targeting treatments		up to 48 months
Secondary	Overall survival for patient treated by fusion-targeting treatments		2 years
Secondary	PFS for patient treated by fusion-targeting treatments	Progression free survival	After 6, 12, 24 months of treatment by fusion targeting treatments
Secondary	Incidence of long-term responders for patient treated by fusion-targeting treatments	> 24 months	up to 48 months
Secondary	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
Secondary	Safety : Nature of adverse reaction (for treatment targeting a fusion)	Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.	up to 48 months
Secondary	Safety : Frequency of adverse reaction (for treatment targeting a fusion)	Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.	up to 48 months
Secondary	Safety : Severity of adverse reaction (for treatment targeting a fusion)	Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.	up to 48 months