NCT04458792

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
79mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Nov 2016Nov 2032

Study Start

First participant enrolled

November 1, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

11 years

First QC Date

June 29, 2020

Last Update Submit

February 11, 2025

Conditions

Sarcoma

Keywords

biological specimen banksradiotherapy

Outcome Measures

Primary Outcomes (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 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

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

    Until the study completion : 5 years

Study Arms (1)

Experimental: Biological collection

EXPERIMENTAL

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 samplesOther: blood sample

Interventions

Paraffin tissue samplesOTHER

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

Experimental: Biological collection
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

Experimental: Biological collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

RECRUITING

Related Publications (6)

  • 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.

    PMID: 21826194RESULT

  • 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.

    PMID: 22517534RESULT

  • 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.

    PMID: 21552124RESULT

  • 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.

    PMID: 25126005RESULT

  • 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.

    PMID: 19498444RESULT

  • 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.

    PMID: 23084521RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • FIRMIN Nelly, MD

    Institut régional du Cancer Montpellier

    STUDY CHAIR

Central Study Contacts

Aurore MOUSSION

CONTACT

4 67 61 31 02DRCI-icm105@icm.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 7, 2020

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2032

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)