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Trial Title: Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS

NCT ID: NCT05739084

Condition: Soft Tissue Sarcomas

Conditions: Official terms:
Sarcoma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Radiation
Intervention name: pre-operative radiation
Description: As per standard of care and institutional guidelines
Arm group label: Prospective cohort
Arm group label: Retrospective cohort

Intervention type: Procedure
Intervention name: Standard surgery after rpreoprative radiation
Description: As per standard of care and institutional guidelines
Arm group label: Prospective cohort
Arm group label: Retrospective cohort

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.

Criteria for eligibility:

Study pop:
Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.

Sampling method: Probability Sample
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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centre Léon Bérard

Address:
City: Lyon
Country: France

Status: Recruiting

Contact:
Last name: Marie-Pierre SUNYACH, MD

Phone: +33 (0)4 78 78 28 28
Email: MariePierre.SUNYACH@lyon.unicancer.fr

Contact backup:
Last name: Waisse Waissi, MD

Phone: +33 (0)4 78 78 28 28
Email: Waisse.WAISSI@lyon.unicancer.fr

Start date: November 23, 2022

Completion date: November 23, 2025

Lead sponsor:
Agency: Centre Leon Berard
Agency class: Other

Source: Centre Leon Berard

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05739084

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