[RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Soft Tissue Sarcomas
- Sponsor
- Centre Leon Berard
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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
Time Frame: 36 months
Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.
Secondary Outcomes
- To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints(36 months)