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

NCT ID: NCT05739084

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2025-11-23

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.

Conditions

Soft Tissue Sarcomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective cohort

A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network)

pre-operative radiation

Intervention Type: RADIATION

As per standard of care and institutional guidelines

Standard surgery after rpreoprative radiation

Intervention Type: PROCEDURE

As per standard of care and institutional guidelines

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.

pre-operative radiation

Intervention Type: RADIATION

As per standard of care and institutional guidelines

Standard surgery after rpreoprative radiation

Intervention Type: PROCEDURE

As per standard of care and institutional guidelines

Interventions

pre-operative radiation

As per standard of care and institutional guidelines

Intervention Type: RADIATION

Standard surgery after rpreoprative radiation

As per standard of care and institutional guidelines

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie -Pierre SUNYACH, MD

Role: CONTACT

MariePierre.SUNYACH@lyon.unicancer.fr

+33(0)4 78 78 28 28

Waisse Waissi, MD

Role: CONTACT

Waisse.WAISSI@lyon.unicancer.fr

+33(0)4 78 78 28 28

Facility Contacts

Marie-Pierre SUNYACH, MD

Role: primary

MariePierre.SUNYACH@lyon.unicancer.fr

+33 (0)4 78 78 28 28

Waisse Waissi, MD

Role: backup

Waisse.WAISSI@lyon.unicancer.fr

+33 (0)4 78 78 28 28

Other Identifiers

GDPR registration Number

Identifier Type: OTHER

Identifier Source: secondary_id

ET21-240 [RADIOSARC]

Identifier Type: -

Identifier Source: org_study_id