Validation of a Genetic Signature to Predict the Development of Sarcomas (PREDISARC)

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.

Study Overview

• Status: Completed
• Conditions: Genetic Signature in Development of Sarcomas
• Intervention / Treatment: Biological: blood sample

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Gilles TRUC, PU PH; Phone Number: 03 80 73 75 18; Email: gtruc@cgfl.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Institu Bergonie
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Group 1: 20 patients with sarcoma developed in irradiated territory
• Group 2: 20 patients treated for cancer by radiotherapy for more than 5 years and who have not developed sarcoma
• Group 3: 20 patients with primary sarcoma

Description

Inclusion Criteria:

1. Major patient at the time of initial radiotherapy or diagnosis of primary sarcoma.

2. Patient belonging to one of these 3 groups :

   Group 1: Patient treated with radiotherapy for cancer other than primary sarcoma and who developed sarcoma (other than osteosarcoma) in the irradiated area.

   OR Group 2: Patient who received radiotherapy for more than 5 years and did not develop sarcoma or other secondary cancers OR Group 3: Patient who developed primary sarcoma and who had never been treated with radiotherapy

3. Patient who have signed informed consent to participate in the study.
4. Affiliation to the social security system.

Exclusion Criteria:

1. Patient unable to understand, read and / or sign informed consent.
2. Person benefiting from a protection system for adults (including guardianship and trusteeship)
3. Pregnant or lactating woman.
4. Patient who participated in the SARI study "Predictive study of sarcomas developed in irradiated territory from the GSF-GETO database (ID-RCB no .: 2011-A01102-39)"

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
radiation-induced sarcomas	Biological: blood sample; 1 tube with 4 ml of blood per patient
radiotherapy for at least 5 years and without sarcomas	Biological: blood sample; 1 tube with 4 ml of blood per patient
primary sarcomas	Biological: blood sample; 1 tube with 4 ml of blood per patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA	Bioinformatic analyzes will be realized out blindly on the 11 genes of the signature to validate determining the group of belonging of the patients	at the inclusion

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Investigators: Principal Investigator: Gilles TRUC, CGFL, Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): June 19, 2022
• Study Completion (Actual): June 19, 2022

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: genetic; sarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: PREDISARC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No