Soft Tissue Sarcomas
Conditions
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.
Interventions
RADIATIONpre-operative radiation
As per standard of care and institutional guidelines
PROCEDUREStandard surgery after rpreoprative radiation
As per standard of care and institutional guidelines
Sponsors
Centre Leon Berard
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 36 months | Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints | 36 months | 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. |
Countries
France
Contacts
Primary ContactMarie -Pierre SUNYACH, MD
Backup ContactWaisse Waissi, MD
Outcome results
None listed