NCT04224064

Brief Summary

The main objective of this project is to identify a new non-invasive biological test for the diagnosis of LPS by measuring circulating serine levels. The current gold standard is the detection of Mdm2 amplification by the FISH.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Aug 2020

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 Progress62%
Aug 2020Dec 2029

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

7.3 years

First QC Date

January 8, 2020

Last Update Submit

February 11, 2025

Conditions

LiposarcomaAtypical Lipomatous Tumor

Keywords

LiposarcomaCancerAtypical Lipomatous TumorNew non-invasive biological test

Outcome Measures

Primary Outcomes (1)

  • Sensibility and specificity of circulating serine level for LPS diagnosis

    Circulating serine level is a quantitative variable evaluated by its concentration

    At 3 months post surgery

Secondary Outcomes (2)

  • Relapse-free survival (RFS)

    Until the study completion: 2 years

  • Difference in circulating serine level

    18 months after surgery

Study Arms (2)

Healthy subjects cohort

EXPERIMENTAL

A single blood sample will be made in healthy subjects.

Diagnostic Test: Blood sampling

Liposarcoma patients cohort

EXPERIMENTAL

Blood samples will be collected at different times: one before induction before surgery and then the second 4 weeks after surgery (+/- 1 week), then every 3 months for 18 months.

Diagnostic Test: Blood sampling

Interventions

Blood samplingDIAGNOSTIC_TEST

Blood samples will be performed in fasted state for the controls and the patients. A single sample will be made in healthy subjects and several samples in patients: one before induction before surgery and then the second 4 weeks after surgery (+/- 1 week), then every 3 months for 18 months.

Healthy subjects cohortLiposarcoma patients cohort

Eligibility Criteria

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

You may qualify if:

  • Men/women older than 18 years old,
  • Surgery for :
  • Localized WD-LPS and DD-LPS, and/or
  • WD-LPS or DD-LPS local relapse, and/or
  • WD-LPS or DD-LPS distant relapse and/or
  • Deep adipocytic tumor greater than 5 cms, suggestive of atypical lipomatous tumor Patient accepting blood sample, Patient who signed informed consent
  • Men/women older than 18 years old, Accepting blood sample, Who signed informed consent Matching on sex and age on LPS patient cohort

You may not qualify if:

  • Pregnancy and/or feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Related Publications (3)

  • Burningham Z, Hashibe M, Spector L, Schiffman JD. The epidemiology of sarcoma. Clin Sarcoma Res. 2012 Oct 4;2(1):14. doi: 10.1186/2045-3329-2-14.

    PMID: 23036164BACKGROUND

  • Smolle MA, Tunn PU, Goldenitsch E, Posch F, Szkandera J, Bergovec M, Liegl-Atzwanger B, Leithner A. The Prognostic Impact of Unplanned Excisions in a Cohort of 728 Soft Tissue Sarcoma Patients: A Multicentre Study. Ann Surg Oncol. 2017 Jun;24(6):1596-1605. doi: 10.1245/s10434-017-5776-8. Epub 2017 Jan 20.

    PMID: 28108827BACKGROUND

  • Chandrasekar CR, Wafa H, Grimer RJ, Carter SR, Tillman RM, Abudu A. The effect of an unplanned excision of a soft-tissue sarcoma on prognosis. J Bone Joint Surg Br. 2008 Feb;90(2):203-8. doi: 10.1302/0301-620X.90B2.19760.

    PMID: 18256089BACKGROUND

MeSH Terms

Conditions

LiposarcomaNeoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSarcoma

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nelly FIRMIN, MD

    Institut Régional du Cancer de Montpellier (ICM)

    STUDY CHAIR

Central Study Contacts

Jean-Pierre BLEUSE, MD

CONTACT

0467613102DRCI-icm105@icm.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

August 26, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)