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

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ClinicalTrials.gov Identifier: NCT04921553
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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.


Condition or disease Intervention/treatment
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 Other: Data collection and quality of life questionnaire

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Management of patient with actionable fusion [ Time Frame: up to 48 months ]
    Treatment scheme : number of line and type of treatments

  2. Time to relapse [ Time Frame: up to 48 months ]
  3. Progression Free Survival (PFS) [ Time Frame: after 6, 12 and 24 months ]
  4. Incidence of long-term responders [ Time Frame: up to 48 months ]
    long term responders =: > 24 months

  5. 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)

  6. Time to relapse for fusion-targeting treatments [ Time Frame: up to 48 months ]
  7. Overall survival for patient treated by fusion-targeting treatments [ Time Frame: 2 years ]
  8. PFS for patient treated by fusion-targeting treatments [ Time Frame: After 6, 12, 24 months of treatment by fusion targeting treatments ]
    Progression free survival

  9. Incidence of long-term responders for patient treated by fusion-targeting treatments [ Time Frame: up to 48 months ]
    > 24 months

  10. 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)

  11. 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.

  12. 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.

  13. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921553


Contacts
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Contact: Julien Bollard 04 78 78 28 28 julien.bollard@lyon.unicancer.fr
Contact: Alexandra BIETTE 04 78 78 28 28 alexandra.biette@lyon.unicancer.fr

Locations
Show Show 41 study locations
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Jean-Yves BLAY, Pr Centre Leon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04921553    
Other Study ID Numbers: ET20000258 TRacKING
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
actionnable fusion
cancer
registry
European reference network