Establishment of a Prospective Clinical-biological Database

Not Applicable

Recruiting

• Conditions: Sarcoma
• Interventions: Other: Paraffin tissue samples; Other: blood sample

• Registration Number: NCT04458792
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Sarcoma

Detailed Description

Liposarcomas (LPS) are soft tissue tumours of mesenchymal origin. The most common histological subtypes, represented by well differenciated Lipsarcomas (WD-LPS) and dedifferenciated (DD-LPS), are characterized by the quasi-systematic amplification of the q13-15 of chromosome 12 containing the Mdm2 gene.

The systematic amplification of the Mdm2 gene is such that it is used clinically to distinguish WD/DD-LPS from other types of sarcomas. These observations raise key questions about the high selection pressure that leads to the almost systematic amplification of Mdm2 during the development of these LPS.

Mdm2 is an oncoprotein whose roles in p53 tumour suppressor degradation are broadly described. However, the different inhibitors targeting this interaction were disappointing in clinical trials.

Recently a team from the U1194 INSERM unit of the IRCM which collaborates in this project showed by a pan-genomics analysis, that Mdm2 is recruited to chromatin within a multiproteic complex having as target a transcriptional program involved in the metabolism and in particular in the biosynthesis of the serin.

This clinical-biological basis will allow the continuation of this research project on liposarcomas and the development of new research projects on other histological types of sarcomas.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2027-11
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• men or women > 18 years
• Patient treated by surgery for : a primitive sarcoma and/or local relapse sarcoma and/or metastatic localisation of sarcoma
• patient accepted blood sample
• patient treated by radiotherapy before or after the surgery
• Patient signed informed consent

Exclusion Criteria

• Patient not affiliated to french Social Protection system
• Patient under guardianship
• Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
• Pregnancy and/or feeding
• Patient take care in an Emergency Situation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Biological collection	Paraffin tissue samples	For all the patients include in the study : * Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue) * MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery * circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery * radiotherapy toxicity : Blood samples collected before the radiotherapy In parallel to this biological collection, standardized clinical data will be entered into a database
Experimental: Biological collection	blood sample	For all the patients include in the study : * Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue) * MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery * circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery * radiotherapy toxicity : Blood samples collected before the radiotherapy In parallel to this biological collection, standardized clinical data will be entered into a database

Primary Outcome Measures

Name	Time	Method
Establishment a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about sarcoma	Until the study completion : 5 years	Number of collection of blood in patients operated on a sarcoma associated with clinical data.

Trial Locations

Locations (1)

Icm Val D'Aurelle; 🇫🇷 Montpellier, Herault, France