Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04458792

Establishment of a Prospective Clinical-biological Database

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraffin tissue samples

Other

Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue

blood sample

Other

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

Primary outcomes

  1. 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

    Time frame: Until the study completion : 5 years

    number of collection of tissue samples (tumour tissue and healthy tissue) in patients operated on a sarcoma associated with clinical data.

  2. 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

    Time frame: Until the study completion : 5 years

    Number of collection of blood in patients operated on a sarcoma associated with clinical data.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

4 67 61 31 02 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Development of a Monocentric and Prospective Clinical and Biological Database in Sarcoma

Acronym: BCBSarcome

Important dates

Study start
2016
Primary completion
2027
Study completion
2032
First posted
Jul 7, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.