Status:
COMPLETED
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
Lead Sponsor:
Bayer
Conditions:
Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion
Infantile Fibrosarcoma
Eligibility:
All Genders
Up to 21 years
Brief Summary
This is an observational study in which data from the past of children and young people with a specific cancer, called NTRK gene fusion positive infantile fibrosarcoma (IFS) is studied. IFS is a rare...
Eligibility Criteria
Inclusion
- Age ≤ 21 years old.
- Locally advanced or metastatic Infantile Fibrosarcoma (IFS).
- Identification of an NTRK gene fusion by a molecular biology assay.
- Patients with available information on clinical, radiological characteristics of their tumor, therapies administered and outcomes.
- Patients receiving larotrectinib in the SCOUT trial.
- Patients receiving at least chemotherapy drugs in the historical control cohort(s).
- No opposition from the patients and/or representatives for data use.
Exclusion
- Patients treated with TRK inhibitors in the historical control cohort(s).
- Patients with documented absence of NTRK gene fusion.
- Patients participating in an investigational program with interventions outside of routine clinical practice.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05236257
Start Date
March 10 2022
End Date
September 13 2022
Last Update
December 10 2024
Active Locations (1)
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1
Multiple Locations
Multiple Locations, France