Identification of a New Blood Biomarker for the Diagnosis and Prognosis of Liposarcomas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sampling
Diagnostic testBlood 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.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Healthy subjects cohortExperimental treatment 1 intervention
Group B: Liposarcoma patients cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensibility and specificity of circulating serine level for LPS diagnosis
Circulating serine level is a quantitative variable evaluated by its concentration
Time frame
At 3 months post surgerySecondary outcomes
1
Relapse-free survival (RFS)
defined as the time measured from the date of surgery treatment to the date of the first documented tumor relapse
Time frame
Until the study completion: 2 years2
Difference in circulating serine level
Measured between the highest and the lowest rates on pre- and post-surgery blood samples
Time frame
18 months after surgerySponsors and contacts
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Source ClinicalTrials.gov