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SarcomaBCBSarcomeNCT04458792

Establishment of a Prospective Clinical-biological Database

A study testing Paraffin tissue samples and blood sample in people with Sarcoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
Paraffin tissue samples and blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteFrance
Study dates
Nov 2016to Nov 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aurore MOUSSION contact

4 67 61 31 02 ext. +33

DRCI-icm105@icm.unicancer.fr

France1 site, 1 recruiting

  • Icm Val D'Aurelle

    Montpellier, Herault, 34298

    Recruiting

Other trials in France

About this study

Official title: 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

Read the 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.

Conditions
Sarcoma
Being tested
Paraffin tissue samples, blood sample
Keywords
biological specimen banks, radiotherapy
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paraffin tissue samplesOther

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

  • blood sampleOther

    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

Study groups in NCT04458792
Study groupRoleWhat they receive
Experimental: Biological collectionExperimentalFor 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
Receives: Other: Paraffin tissue samples; Other: blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Measured: Until the study completion : 5 years

  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

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

    Measured: Until the study completion : 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study startNov 2016
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458792
Sponsor's protocol ID
ICM-BDD 2016/03
Acronym
BCBSarcome
Status last verified
Feb 2025
First submitted
29 Jun 2020
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ducimetiere F, Lurkin A, Ranchere-Vince D, Decouvelaere AV, Peoc'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 in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.

    PubMed 21826194

  • Mastrangelo G, Coindre JM, Ducimetiere F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchere-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 European regions. Cancer. 2012 Nov 1;118(21):5339-48. doi: 10.1002/cncr.27555. Epub 2012 Apr 19.

    PubMed 22517534

  • 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.

    PubMed 21552124

  • Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Ruschoff 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. eCollection 2014.

    PubMed 25126005

  • 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.

    PubMed 19498444

  • 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-differentiated or dedifferentiated liposarcoma: an exploratory proof-of-mechanism study. Lancet Oncol. 2012 Nov;13(11):1133-40. doi: 10.1016/S1470-2045(12)70474-6. Epub 2012 Oct 17.

    PubMed 23084521

Questions about this trial

What is this clinical trial studying?

A study testing Paraffin tissue samples and blood sample in people with Sarcoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurore MOUSSION (4 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458792, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

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