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Real Word European Registry o...

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

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-22

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Yves BLAY, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

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