Establishment of a Prospective Clinical-biological Database (BCBSarcome)

November 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Herault
      • Montpellier, Herault, France, 34298
        • Recruiting
        • ICM Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Biological collection

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
Other: Paraffin tissue samples
Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue
Other: blood sample
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until the study completion : 5 years
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.
Until the study completion : 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: FIRMIN Nelly, MD, Institut régional du Cancer Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-BDD 2016/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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