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

Not Applicable

Active, not recruiting

• Conditions: Soft Tissue Sarcoma; Advanced Cancer; Metastatic Cancer

• Registration Number: NCT03375437
• Lead Sponsor: Centre Leon Berard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the proportion of patients with NTRK1/2/3, ROS1 or ALK gene fusions (95% confidence interval)

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with NTRK1/2/3, ROS1, or ALK gene fusion per histological sub-types of STS with complex genomics;Clinical characteristics of patients with NTRK1/2/3, ROS1, or ALK gene fusion versus patients with no NTRK1/2/3, ROS1, or ALK gene fusion.;anti-cancer treatments initiated since inclusion.;Overall survival (OS)