CancerTRacKINGNCT04921553
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
An observational study of Cancer and Cancer Metastatic, run by Centre Leon Berard at 41 sites in 11 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Metastatic, NTRK Gene Fusion Overexpression
- What is being tested?
- Data collection and quality of life questionnaire
- How many people
- 500 participants
- Where
- 41 sitesin 11 countries
- Study dates
- 22 Jun 2021to Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
41 sites in 11 countries.
41 sites in 11 countries
France14 sites, 14 recruiting
- Not yet recruiting
Chu Jean Minjoz
Besançon
Loic CHAIGNEAU
- Recruiting
Institut Bergonie
Bordeaux
Antoine ITALIANO
- Not yet recruiting
Centre Georges Francois Leclerc
Dijon
Alice HERVIEU
- Not yet recruiting
Centre Oscar Lambret
Lille, 59020
Nicolas PENEL
- Not yet recruiting
Chu Dupuytren
Limoges
Valérie LE BRUN LY
- Recruiting
Centre Léon Bérard
Lyon, 69008
Julien Bollard, julien.bollard@lyon.unicancer.fr
Alexandra Biette, alexandra.biette@lyon.unicancer.fr
- Not yet recruiting
Assistance Publique Hopitaux de Marseille (AP-HM)
Marseille
Marie Eve GARCIA
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Esma SAADA-BOUZID
- Not yet recruiting
Institut Curie
Paris, 75005
Sarah WATSON
Sarah WATSON
- Not yet recruiting
Aphp - Hopital de La Pitie Salpetriere
Paris, 75013
Jean-Philippe SPANO
- Not yet recruiting
Aphp - Hopital Cohin
Paris, 75014
Pascaline BOUDOU-ROUQUETTE
- Not yet recruiting
Aphp - Hopital Tenon
Paris, 75020
Jean-Pierre LOTZ
- Not yet recruiting
Centre Henri Becquerel
Rouen
Cécile GUILLEMET
- Not yet recruiting
Institut Claudius Regaud
Toulouse
Thibaud VALENTIN
Germany11 sites, 11 recruiting
- Not yet recruiting
"Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"
Aschaffenburg
Manfred WELSLAU
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin
Jalid SEHOULI
- Not yet recruiting
"Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"
Chemnitz
Mathias HANEL
- Not yet recruiting
"Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"
Frankfurt am Main
Jorg TROJAN
- Not yet recruiting
"Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"
Halle
Haifa Kathrin Al-Ali
- Not yet recruiting
"Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"
Magdeburg
Marino Venerito
- Not yet recruiting
Mannheim University Medical Center (UniversitatsMedizin Mannheim)
Mannheim
Bernd KASPER
- Not yet recruiting
"Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"
München
Volker HEINEMANN
- Not yet recruiting
"Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"
Nordhausen
Hans-Heinrich WOLF
- Not yet recruiting
Universitätsklinikum Tübingen Medizinische Universitätsklinik;
Tübingen
Constantin Roder
- Not yet recruiting
University Hospital Würzburg (UniversitätsKlinikum Würzburg)
Würzburg
Volker KUNZMANN
Italy6 sites, 6 recruiting
- Not yet recruiting
Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna
Bologna
Maria Abbondenza PANTALEO
- Not yet recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Toni IBRAHIM
- Not yet recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Marica EOLI
- Not yet recruiting
IRCCS Ospedale San Raffale
Milan
Alice BERGAMINI
- Not yet recruiting
CRTR-AOU Federico II
Naples
Mario GIULIANO
- Not yet recruiting
Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino
Torino
Riccardo SOFFIETTI
Austria2 sites, 2 recruiting
- Not yet recruiting
University Hospital Graz
Graz
Andreas LEITNER
- Not yet recruiting
Medical University of Vienna
Vienna
Thomas BRODOWICZ
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
The Royal Marsden NHS Foundation Trust
London
Robin JONES
- Not yet recruiting
University College London NHS Foundation Trust
London
John BRIDGEWATER
Czechia1 site, 1 recruiting
- Not yet recruiting
Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)
Brno
Jana Halámková
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus
Ninna Aggerholm
Netherlands1 site, 1 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden
Ellen KAPITEIJN
Poland1 site, 1 recruiting
- Not yet recruiting
Maria Sklodowska Curie National Research Institute of Oncology
Warsaw
Iwona LUGOWSKA
Slovenia1 site, 1 recruiting
- Not yet recruiting
Institute of Oncology of Ljubljana
Ljubljana
Mojca UNK
Spain1 site, 1 recruiting
- Not yet recruiting
Complejo Hospitalario regional Virgen del Rocio
Seville
Javier MARTIN-BROTO
About this study
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.
Read the detailed description
- Administrative opening of the center
- Routine identification of a patients harboring a rare actionable fusion
- 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).
- Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.
- Conditions
- Cancer, Cancer Metastatic, NTRK Gene Fusion Overexpression, NTRK Family Gene Mutation, ATIC-ALK Fusion Protein Expression, ALK Fusion Protein Expression
- Being tested
- Data collection and quality of life questionnaire
- Keywords
- actionnable fusion, cancer, registry, European reference network
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and quality of life questionnaireOther
- Data collection from the medical file
- Quality of life questionnaire (QLQC30) at inclusion, at each change of treatment and then every 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (13)
Management of patient with actionable fusion
Treatment scheme : number of line and type of treatments
Measured: up to 48 months
Time to relapse
Measured: up to 48 months
Progression Free Survival (PFS)
Measured: after 6, 12 and 24 months
Incidence of long-term responders
long term responders =: > 24 months
Measured: up to 48 months
Quality of life of patient
To evaluate patient-reported outcomes concerning individual QoL according to QLQ-C30 (EORTC Quality of Life questionnaires)
Measured: After 6, 12, 18, 24, 30, 36, 42, 48 months
Time to relapse for fusion-targeting treatments
Measured: up to 48 months
Overall survival for patient treated by fusion-targeting treatments
Measured: 2 years
PFS for patient treated by fusion-targeting treatments
Progression free survival
Measured: After 6, 12, 24 months of treatment by fusion targeting treatments
Incidence of long-term responders for patient treated by fusion-targeting treatments
> 24 months
Measured: up to 48 months
Quality of life of patient treated by fusion-targeting treatments
using QLQC30 (EORTC Quality of Life questionnaires)
Measured: After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments
Safety : Nature of adverse reaction (for treatment targeting a fusion)
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Measured: up to 48 months
Safety : Frequency of adverse reaction (for treatment targeting a fusion)
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Measured: up to 48 months
Safety : Severity of adverse reaction (for treatment targeting a fusion)
Using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start22 Jun 2021
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves BLAY, Pr, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921553
- Sponsor's protocol ID
- ET20000258 TRacKING
- Acronym
- TRacKING
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
- ClinicalTrials.gov ID
- NCT04921553
- Acronym / sponsor ID
- TRacKING / ET20000258 TRacKING
- Conditions
- Cancer, Cancer Metastatic, NTRK Gene Fusion Overexpression, NTRK Family Gene Mutation, ATIC-ALK Fusion Protein Expression, ALK Fusion Protein Expression
- Keywords
- actionnable fusion, cancer, registry, European reference network
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Administrative opening of the center
- Routine identification of a patients harboring a rare actionable fusion
- 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).
- Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with histologically-confirmed cancer that harboring a rare actionnable fusion, treated in a European center
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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)
13 secondary outcomes
Management of patient with actionable fusion
Time frame: up to 48 months
Time to relapse
Time frame: up to 48 months
Progression Free Survival (PFS)
Time frame: after 6, 12 and 24 months
Incidence of long-term responders
Time frame: up to 48 months
Quality of life of patient
Time frame: After 6, 12, 18, 24, 30, 36, 42, 48 months
Time to relapse for fusion-targeting treatments
Time frame: up to 48 months
Overall survival for patient treated by fusion-targeting treatments
Time frame: 2 years
PFS for patient treated by fusion-targeting treatments
Time frame: 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
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
Safety : Nature of adverse reaction (for treatment targeting a fusion)
Time frame: up to 48 months
Safety : Frequency of adverse reaction (for treatment targeting a fusion)
Time frame: up to 48 months
Safety : Severity of adverse reaction (for treatment targeting a fusion)
Time frame: up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves BLAY, Pr principal investigator
Centre Leon Berard
41 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Metastatic, run by Centre Leon Berard at 41 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in France, Germany, Italy, Austria, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Bollard (04 78 78 28 28, julien.bollard@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.