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RecruitingNCT04224064ESPACEUpdated Feb 12, 2025

Identification of a New Blood Biomarker for the Diagnosis and Prognosis of Liposarcomas

An interventional study of Blood sampling in Liposarcoma and Atypical Lipomatous Tumor, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Aug 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Sarcomas are rare diseases, accounting for less than 1% of all malignant diseases in adults¹. Their incidence is about 6 new cases per 100,000 in inhabitants per year, ie 4,000 to 5,000 new cases estimated per year in France.

Liposarcoma (LPS) is the most common soft tissue sarcoma subtype, accounting for approximately 15% of all sarcomas.

The OMS classification distinguishes 5 categories of LPS: myxoid, pleomorphe, round-cell liposarcomas, dedifferentiated (DD-LPS) and well-differentiated (WD-LPS). Research team is interested by the last two in this study.

The diagnosis is suspected on the imaging examinations (MRI for limb tumors and CT for retro-peritoneal LPS) which should lead to a discussion at a multidisciplinary tumor board in an expert center to validate the biopsy for definitive diagnosis and define the best biopsy route to avoid the risk of spread. In France, the management of patients with sarcoma is organized around the network of 24 "NETSARC" centers.

WD-LPS and DD-LPS, may be difficult to distinguish from benign adipose tumors and undifferentiated sarcomas, respectively. Molecular analyze, based on the detection of Mdm2 gene amplification by Fluorescence in situ Hybridization (FISH) is currently the "gold standard". It is performed on a tumor biopsy. The biopsy is a radiologic biopsy as it is recommended in the guidelines to reduce the risk of disease spread. The material allowing the diagnosis is thus limited complicating the realization of morphology, immunohistochemistry and molecular biology on the same sample. The other limitation is that this tumor fragment does not always reflect intra-tumor heterogeneity.

The treatment is surgical with monobloc resection by a surgeon specialized in sarcomas. Despite surgical excision, the risk of local and distant recurrence is approximately 26% for well-differentiated liposarcomas⁵ and up to 59% for dedifferentiated retroperitoneal liposarcomas. Prognostic factors for recurrence are the quality of excision, tumor size, grade, and retroperitoneal / limb localization. The problematic concerning these 2 types of liposarcomas is not the same. In WD-LPS, the question is to know the risk of recurrence in case of unplanned R1 resection (representing approximately 50% of initial surgeries). Indeed a systematic surgical revision of all these cases is expensive and morbid whereas in 50% of cases no tumor residue will be found on the surgical recovery. For the DD-LPS the problem is different because the surgical revision must be systematic in case of non-R0 surgery, but it is the risk of local recurrence despite adequate surgery and the metastatic risk that must be evaluated in order to propose an adjuvant treatment (chemotherapy and / or radiotherapy) to patients with a high risk of recurrence also making it essential to identify a biological factor of prognosis to select patients with a high risk of relapse.

Clinicians propose to identify a new blood test that would indicate the presence of the disease. It would then serve for the diagnosis but also prognosis allowing us to evaluate the residual disease after surgery of excision. Due to the complexity of sarcomas, identifying an effective and reliable biomarker for WD-LPS and DD-LPS with non-invasive methods is a challenge, but clinicians hope that their project will provide a more efficient and patient-friendly method for the detection of the disease. Our project relies on the complementary expertise provided by clinicians, researchers and biostatisticians in close collaboration.

Clinicians have recently characterized a novel function of the p53 independent Mdm2 protein in serine metabolism, which could play a fundamental role in the development of LPS. Through pan-genome approaches clinicians have characterized a novel transcriptional activity of Mdm2 and demonstrated its role in the metabolism of cancer cells. These data indicate that the presence of Mdm2 at chromatin makes it possible to control the transcription of genes involved in the metabolism and transport of certain amino acids such as serine.

The endogenous serine pool is maintained by a balance between auxotrophy and de novo synthesis, that are strongly deregulated during cell transformation to support the anabolic needs of cancer cells. Mdm2 is recruited via transcription factors of the ATF family on target genes involved in de novo synthesis and serine transport.

Clinicians propose to identify a biological test for the prognosis and diagnosis of LPS that does not require invasive biopsy. Patients included in the study will be patients with WD-LPS or DD-LPS, with the goal of including 100 patients over 2 years.

Based on recent data showing that LPS growth is mediated by Mdm2-mediated regulation of serine metabolism, clinicians propose to measure serine blood levels as a surrogate marker for LPS development. To maintain the intracellular level of serine, Mdm2 controls both de novo serine synthesis (a metabolic pathway that uses the glycolytic intermediate 3-Phospho-Glycerate to generate serine in cells) and the entry of the serine in the cell by auxotrophy. Given the size of LPS, which can often reach several tens of centimeters, clinicians hypothesized that LPS may result in significant demand for serine that could be produced by the microenvironment and transmitted to the tumor by circulating pools of serine and glycine (which can be inter-converted to serine by cells). The profiling of plasma amino acids is of great clinical interest since they are easy to measure by liquid chromatography (HPLC). Clinicians have already validated an HPLC method to measure different amino acids, including serine and glycine, in the serum. Our preliminary data are in line with our hypothesis since the serum serine level is higher in the xenografted mice with patient tumor compared to serum levels measured in the control mice. In addition, in response to treatment with an Mdm2 inhibitor, which induces a drastic reduction in tumor growth, a decrease in circulating serine can be observed.

Clinicians will use an HPLC coupled with mass spectrometry already developed to measure amino acids from Agilent technology. The quantitative analysis of amino acids combines speed and sensitivity with the reliability of the derivation reaction and the analytical technique. These goals are achieved by automated and online derivatization using o-phthalaldehyde (OPA) for primary amino acids and 9-fluorenylmethyl chloroformate (FMOC) for secondary amino acids. Automated derivation is then integrated into robust HPLC analysis. The complete procedure is fast, accurate, sensitive and reproducible using Agilent 1190 HPLC.

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.

02

Conditions studied

  • Liposarcoma
  • Atypical Lipomatous Tumor

Keywords

  • Liposarcoma
  • Cancer
  • Atypical Lipomatous Tumor
  • New non-invasive biological test
03

In context

Liposarcoma

160 studies on the registry are indexed under Liposarcoma; 36 are open to participants now.

This study's planned enrollment of 158 is above the median of 52 across 136 interventional studies indexed under Liposarcoma.

Browse Liposarcoma studies →

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for LPS patients cohort:

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

Inclusion Criteria for healthy subjects cohort:

Men/women older than 18 years old, Accepting blood sample, Who signed informed consent Matching on sex and age on LPS patient cohort

Exclusion Criteria:

Presence of Treatment for the present cancer, Unaffiliated patient to French Social Protection System, Patient whose follow up is impossible for psychologic, social, geographic, familial reasons Psychiatric illness that would prevent the patient from giving informed consent or being compliant with the study procedures Patient who have another cancer within the 5 years of the inclusion except in situ breast carcinoma, in situ, basocellular carcinoma.

Pregnancy and/or feeding

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (estimated)

Study arms

  • Experimental
    Healthy subjects cohort

    A single blood sample will be made in healthy subjects.

    Diagnostic Test: Blood sampling

  • Experimental
    Liposarcoma patients cohort

    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

  • Diagnostic testBlood sampling

    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.

06

What researchers measure

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 surgery

Secondary 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 years

  2. 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 surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 23036164 ↗
  • 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. PubMed 28108827 ↗
  • 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. PubMed 18256089 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2020 (actual). Primary completion is estimated for Dec 2027, 88 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2020
First posted
Jan 13, 2020
StartActual
Aug 26, 2020
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2029
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04224064
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Aug 26, 2020
Primary completion
Dec 2027 (estimated)
Completion
Dec 2029 (estimated)
Last update
Feb 12, 2025

Study contacts

Jean-Pierre BLEUSE, MD
Contact
DRCI-icm105@icm.unicancer.fr
0467613102 ext. +33
Nelly FIRMIN, MD
study chair · Institut Régional du Cancer de Montpellier (ICM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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