Validation of a Genetic Signature to Predict the Development of Sarcomas

NCT03625791 | Completed

• 1 other identifier: PREDISARC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Genetic Signature in Development of Sarcomas

Keywords

sarcoma; genetic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

radiation-induced sarcomas

Biological: blood sample

radiotherapy for at least 5 years and without sarcomas

Biological: blood sample

primary sarcomas

Biological: blood sample

Interventions

blood sample BIOLOGICAL

1 tube with 4 ml of blood per patient

primary sarcomas; radiation-induced sarcomas; radiotherapy for at least 5 years and without sarcomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Major patient at the time of initial radiotherapy or diagnosis of primary sarcoma.
• 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
• Patient who have signed informed consent to participate in the study.
• Affiliation to the social security system.

You may not qualify if:

• Patient unable to understand, read and / or sign informed consent.
• Person benefiting from a protection system for adults (including guardianship and trusteeship)
• Pregnant or lactating woman.
• 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)"

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (3)

Institu Bergonie

Bordeaux, 33076, France

Location

Centre Georges François Leclerc

Dijon, 21000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gilles TRUC

  CGFL, Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: June 19, 2018
• Primary Completion: June 19, 2022
• Study Completion: June 19, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FR (3)