Clinical trial NCT05739084: Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS
Official title: [RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Tissue Sarcomas
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.

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.

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)

Primary outcomes:
measure: 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
timeFrame: 36 months
Secondary outcomes:
measure: To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints
timeFrame: 36 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
References: