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Status:

ACTIVE_NOT_RECRUITING

RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions.

Lead Sponsor:

Centre Leon Berard

Collaborating Sponsors:

Hoffmann-La Roche

Conditions:

Soft Tissue Sarcoma

Advanced Cancer

Eligibility:

All Genders

12+ years

Phase:

NA

Brief Summary

This trial is a multicenter, prospective cohort study aiming to describe molecular profiles of soft tissue sarcoma (STS) with complex genomic profiles in particular to assess the incidence of NTRK1/2/...

Detailed Description

Following inform consent form (ICF) signature, a formalin-fixed and paraffin-embedded (FFPE) tumor block (archival or a dedicated freshly collected tumor biopsy) will be collected for all enrolled pat...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • I1. Male or female patients aged ≥ 12 years at time of informed consent form (ICF) signature.
  • I2. Histologically confirmed diagnosis of advanced /metastatic disease STS with complex genomics (e.g., Leiomyosarcoma \[LMS\], Undifferentiated Pleomorphic Sarcoma \[UPS\], pleomorphic liposarcoma/rhabdomyosarcoma \[P-LPS/P-RMS\], angiosarcoma, malignant peripheral nerve sheath tumor \[MPNST\], myxofibrosarcoma, fibrosarcoma).
  • I3. Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report:
  • either a tumor archival block (less than 3 years old) or a dedicated freshly collected de novo biopsy performed from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm.
  • I4. Tumor sample meeting following quality/quantity control (QC) criteria confirmed by a central pathological review:
  • at least 20% (ideally 30%) of tumor cells and a sample size surface area \> 5mm2 (ideally 5-25mm2).
  • I5. Patient (and legal guardians if not-emancipated minor) should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study procedures as per protocol.
  • I6. Patient must be covered by a medical insurance.
  • Non-inclusion criteria:
  • NI1. Patients with non-assessable tumor sample.
  • NI2. Prior treatment with approved or investigational TRK, ROS1, or ALK inhibitors. Any other prior anticancer therapy are allowed with no limit of prior number of treatment lines.
  • NI3. Pregnant or breast-feeding patients.

Exclusion

    Key Trial Info

    Start Date :

    February 15 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 15 2025

    Estimated Enrollment :

    376 Patients enrolled

    Trial Details

    Trial ID

    NCT03375437

    Start Date

    February 15 2018

    End Date

    December 15 2025

    Last Update

    August 26 2024

    Active Locations (10)

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    Page 1 of 3 (10 locations)

    1

    Centre Jean Perrin

    Clermont-Ferrand, France, 63011

    2

    Centre Georges-Francois Leclerc

    Dijon, France, 21079

    3

    Centre Oscar Lambret

    Lille, France, 59000

    4

    CHU de Limoges Hôpital Dupuytren

    Limoges, France