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

July 27, 2021 updated by: Centre Leon Berard

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Not yet recruiting
        • University Hospital Graz
        • Principal Investigator:
          • Andreas LEITNER
      • Vienna, Austria
        • Not yet recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Thomas BRODOWICZ
  • Czechia
      • Brno, Czechia
        • Not yet recruiting
        • Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)
        • Principal Investigator:
          • Jana Halámková
  • Denmark
      • Aarhus, Denmark
        • Not yet recruiting
        • Aarhus University Hospital
        • Principal Investigator:
          • Ninna Aggerholm
  • France
      • Besançon, France
        • Not yet recruiting
        • CHU Jean Minjoz
      • Bordeaux, France
        • Recruiting
        • Institut Bergonie
      • Dijon, France
        • Not yet recruiting
        • Centre Georges François Leclerc
      • Lille, France, 59020
        • Not yet recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Nicolas Penel
      • Limoges, France
        • Not yet recruiting
        • Chu Dupuytren
        • Principal Investigator:
          • Valérie LE BRUN LY
      • Lyon, France, 69008
      • Marseille, France
        • Not yet recruiting
        • Assistance Publique Hopitaux de Marseille (AP-HM)
        • Principal Investigator:
          • Marie Eve GARCIA
      • Nice, France
        • Not yet recruiting
        • Centre Antoine Lacassagne
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Sarah WATSON
        • Principal Investigator:
          • Sarah Watson
      • Paris, France, 75013
        • Not yet recruiting
        • APHP - Hopital de la Pitie Salpetriere
        • Principal Investigator:
          • Jean-Philippe SPANO
      • Paris, France, 75014
        • Not yet recruiting
        • Aphp - Hopital Cohin
        • Principal Investigator:
          • Pascaline BOUDOU-ROUQUETTE
      • Paris, France, 75020
        • Not yet recruiting
        • APHP - Hôpital Tenon
        • Principal Investigator:
          • Jean-Pierre LOTZ
      • Rouen, France
        • Not yet recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Cécile GUILLEMET
      • Toulouse, France
        • Not yet recruiting
        • Institut Claudius Regaud
        • Principal Investigator:
          • Thibaud VALENTIN
  • Germany
      • Aschaffenburg, Germany
        • Not yet recruiting
        • "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"
        • Principal Investigator:
          • manfred Welslau
      • Berlin, Germany
        • Not yet recruiting
        • Charité - Universitätsmedizin Berlin
        • Principal Investigator:
          • Jalid SEHOULI
      • Chemnitz, Germany
        • Not yet recruiting
        • "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"
        • Principal Investigator:
          • Mathias HANEL
      • Frankfurt am main, Germany
        • Not yet recruiting
        • "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"
        • Principal Investigator:
          • Jorg TROJAN
      • Halle, Germany
        • Not yet recruiting
        • "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"
        • Principal Investigator:
          • Haifa Kathrin Al-Ali
      • Magdeburg, Germany
        • Not yet recruiting
        • "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"
        • Principal Investigator:
          • Marino Venerito
      • Mannheim, Germany
        • Not yet recruiting
        • Mannheim University Medical Center (UniversitatsMedizin Mannheim)
        • Principal Investigator:
          • Bernd Kasper
      • München, Germany
        • Not yet recruiting
        • "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"
        • Principal Investigator:
          • Volker Heinemann
      • Nordhausen, Germany
        • Not yet recruiting
        • "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"
        • Principal Investigator:
          • Hans-Heinrich WOLF
      • Tübingen, Germany
        • Not yet recruiting
        • Universitätsklinikum Tübingen Medizinische Universitätsklinik;
        • Principal Investigator:
          • Constantin Roder
      • Würzburg, Germany
        • Not yet recruiting
        • University Hospital Würzburg (UniversitätsKlinikum Würzburg)
        • Principal Investigator:
          • Volker KUNZMANN
  • Italy
      • Bologna, Italy
        • Not yet recruiting
        • Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna
        • Principal Investigator:
          • Maria Abbondenza PANTALEO
      • Meldola, Italy
        • Not yet recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
        • Principal Investigator:
          • Toni IBRAHIM
      • Milano, Italy
        • Not yet recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Principal Investigator:
          • Marica Eoli
      • Milano, Italy
        • Not yet recruiting
        • IRCCS Ospedale San Raffale
        • Principal Investigator:
          • Alice BERGAMINI
      • Napoli, Italy
        • Not yet recruiting
        • CRTR-AOU Federico II
        • Principal Investigator:
          • Mario GIULIANO
      • Torino, Italy
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino
        • Principal Investigator:
          • Riccardo Soffietti
  • Netherlands
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center
        • Principal Investigator:
          • Ellen Kapiteijn
  • Poland
      • Warsaw, Poland
        • Not yet recruiting
        • Maria Sklodowska Curie National Research Institute of Oncology
  • Slovenia
      • Ljubljana, Slovenia
        • Not yet recruiting
        • Institute of Oncology of Ljubljana
        • Principal Investigator:
          • Mojca UNK
  • Spain
      • Sevilla, Spain
        • Not yet recruiting
        • Complejo Hospitalario regional Virgen del Rocio
        • Principal Investigator:
          • javier martin-broto
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • The Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • ROBIN JONES
      • London, United Kingdom
        • Not yet recruiting
        • University College London NHS Foundation Trust
        • Principal Investigator:
          • John Bridgewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Management of patient with actionable fusion
Time Frame: up to 48 months
Treatment scheme : number of line and type of treatments
up to 48 months
Time to relapse
Time Frame: up to 48 months
up to 48 months
Progression Free Survival (PFS)
Time Frame: after 6, 12 and 24 months
after 6, 12 and 24 months
Incidence of long-term responders
Time Frame: up to 48 months
long term responders =: > 24 months
up to 48 months
Quality of life of patient
Time Frame: 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)
After 6, 12, 18, 24, 30, 36, 42, 48 months
Time to relapse for fusion-targeting treatments
Time Frame: up to 48 months
up to 48 months
Overall survival for patient treated by fusion-targeting treatments
Time Frame: 2 years
2 years
PFS for patient treated by fusion-targeting treatments
Time Frame: After 6, 12, 24 months of treatment by fusion targeting treatments
Progression free survival
After 6, 12, 24 months of treatment by fusion targeting treatments
Incidence of long-term responders for patient treated by fusion-targeting treatments
Time Frame: up to 48 months
> 24 months
up to 48 months
Quality of life of patient treated by fusion-targeting treatments
Time Frame: After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments
using QLQC30 (EORTC Quality of Life questionnaires)
After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments
Safety : Nature of adverse reaction (for treatment targeting a fusion)
Time Frame: up to 48 months
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
up to 48 months
Safety : Frequency of adverse reaction (for treatment targeting a fusion)
Time Frame: up to 48 months
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
up to 48 months
Safety : Severity of adverse reaction (for treatment targeting a fusion)
Time Frame: up to 48 months
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Jean-Yves BLAY, Pr, Centre Léon Bérard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ET20000258 TRacKING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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