Establishment of a Prospective Clinical-biological Database

Sarcoma Clinical Trial

— BCBSarcome  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458792
• Other study ID #: ICM-BDD 2016/03
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2027

Study information

• Verified date: November 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: BLEUSE Jean-Pierre, MD
• Phone: 4 67 61 31 00
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: November 2027
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

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

Locations

Country	Name	City	State
France	Icm Val D'Aurelle	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (6)

Crago AM, Singer S. Clinical and molecular approaches to well differentiated and dedifferentiated liposarcoma. Curr Opin Oncol. 2011 Jul;23(4):373-8. doi: 10.1097/CCO.0b013e32834796e6. Review. — View Citation

Ducimetière F, Lurkin A, Ranchère-Vince D, Decouvelaere AV, Péoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes — View Citation

Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Rüschoff J, Schildhaus HU. Challenging dedifferentiated liposarcoma identified by MDM2-amplification, a report of two cases. BMC Clin Pathol. 2014 Jul 28;14:36. doi: 10.1186/1472-6890-14-36. eCollectio — View Citation

Marine JC, Lozano G. Mdm2-mediated ubiquitylation: p53 and beyond. Cell Death Differ. 2010 Jan;17(1):93-102. doi: 10.1038/cdd.2009.68. Review. — View Citation

Mastrangelo G, Coindre JM, Ducimetière F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchère-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 E — View Citation

Ray-Coquard I, Blay JY, Italiano A, Le Cesne A, Penel N, Zhi J, Heil F, Rueger R, Graves B, Ding M, Geho D, Middleton SA, Vassilev LT, Nichols GL, Bui BN. Effect of the MDM2 antagonist RG7112 on the P53 pathway in patients with MDM2-amplified, well-differ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	Number of collection of blood in patients operated on a sarcoma associated with clinical data.	Until the study completion : 5 years