TRacKING v1.2
Research type
Research Study
Full title
Real world European registry of NTRK fusions and other rare actionable fusions
IRAS ID
307687
Contact name
Jean-Yves BLAY, MH, PhD
Contact email
Sponsor organisation
Centre de Lutte Contre le Cancer Léon Bérard
Clinicaltrials.gov Identifier
NCT04921553, ClinicalTrials.gov Identifier (NCT number):
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cancer is caused by a change (called an alteration) that has occurred in one or more genes. Gene fusions are rare alterations that can lead to cancer. Fusions are the mix of 2 or more genes, leading to the formation of a new gene.
The objective of this study is to gather collect data from adult cancer patients harboring NTRK gene fusions or other actionable fusions which is to be transferred to a Research Database located in France.
TRacKING is a registry study. A registry is a continuous collection of data about information on the number of patients suffering from a disease as well as on the characteristics of the patients (age, sex,…) and of the disease (diagnosis, treatments, ...) for research purposes and public health, by a team with the appropriate skills.
This registry was created to follow the evolution of patients with fusions to better understand the evolution of these rare cancers, and to potentially identify patients for future clinical trials. This registry will also make it possible to assess the safety and efficacy of new targeted therapies, in a real-life setting.
Participants will need to complete a quality of life questionnaire upon enrolment in the study, then at each change of treatment and every 6 months. In addition, personal and clinical data will be collected from the participants medical file. The study will take place over a 4 year-period and participation will last at least 2 years. The paticipant's care will not be modified by their participation in this study. The participant's care will continue as normal.
Up to 500 patients from various European countries are expected to be included in the study however the protocol may be amended to include more patients.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0073
Date of REC Opinion
26 May 2022
REC opinion
Further Information Favourable Opinion