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This is a molecular screening program that uses blood and tumor samples to detect NTRK1/2/3, ROS1 or ALK gene fusions in patients with soft tissue sarcoma that has a complex genomic profile. Patients aged 12 years and older with advanced or metastatic soft tissue sarcoma may take part. It is run as a screening study with no assigned phase and is currently not recruiting but still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.