Soft Tissue Sarcomas Clinical Trial
— RADIOSARCOfficial title:
[RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients
Status | Recruiting |
Enrollment | 300 |
Est. completion date | November 23, 2025 |
Est. primary completion date | June 23, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female = 18 years at time of non-opposition to participate to the study - Patient with documented non-opposition to participate to the study. - Patient with histologically and cytologically confirmed diagnosis with STS (..) - Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional). - Patients with tumor FFPE samples prepared with the last 4 years - Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..) Exclusion Criteria: - Patients with metastatic soft tissue sarcoma at diagnosis - Patients with exclusive radiotherapy without surgical resection - Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy) |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint | Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response. | 36 months | |
Secondary | To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints | Gene expression signature using RNAseq correlated to the percentage of necrosis, the percentage of fibrosis, the local control at 1 and 2 years (1- and 2-year local / distant recurrence-free survival, the time To Relapse (TTR), the Disease Free Survival (DFS), The Quality of resection level based on the residual tumor (R) classification. | 36 months |
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