To hear about similar clinical trials, please enter your email below
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
