NCT03625791

Validation of a Genetic Signature to Predict the Development of Sarcomas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma. Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones. The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.

Detailed description

A total of 60 patients will be included in this pilot study: * Group 1: 20 patients with induced radio sarcoma * Group 2: 20 patients without primary sarcoma or induced radio sarcoma * Group 3: 20 patients with primary sarcoma These numbers will make it possible to have preliminary data making it possible to judge the interest of the genetic signature in the prediction of the radiation-induced sarcomas.

Conditions

• Genetic Signature in Development of Sarcomas

Interventions

Type	Name	Description
BIOLOGICAL	blood sample	1 tube with 4 ml of blood per patient

Timeline

• Start date: 2018-06-19
• Primary completion: 2022-06-19
• Completion: 2022-06-19
• First posted: 2018-08-10
• Last updated: 2024-02-13

Locations

3 sites across 1 country: France