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| ID | Type | Description | Link |
|---|---|---|---|
| GDPR registration Number | Other Identifier | R201-004-171 |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network) |
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| Prospective cohort | To ensure an external validation, patients from NETsarc centers experiencing preoperative RT will be prospectively accrued and transcriptomic signature will be tested. Up to 100 patients will be enrolled in this prospective cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-operative radiation | Radiation | As per standard of care and institutional guidelines |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie -Pierre SUNYACH, MD | Contact | +33(0)4 78 78 28 28 | MariePierre.SUNYACH@lyon.unicancer.fr | |
| Waisse Waissi, MD | Contact | +33(0)4 78 78 28 28 | Waisse.WAISSI@lyon.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Available FFPE Tumour samples at diagnosis and surgery from respectively Retrospective cohort [200 patients] and Propective Cohort [100 patients]
| Standard surgery after rpreoprative radiation | Procedure | As per standard of care and institutional guidelines |
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| 36 months |