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Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

ConditionsSoft Tissue SarcomaClear Cell SarcomaEpithelioid SarcomaPerivascular Epithelioid Cell NeoplasmsDesmoplastic Small Round Cell TumorMalignant Solitary Fibrous TumorsAlveolar Soft Part SarcomaEpithelioid HemangioendotheliomaLow Grade Fibromyxoid SarcomaSclerosing Epithelioid Fibrosarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud

About this trial

This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.

400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.

Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of study entry.

Clear Cell Sarcoma (CCS)

Epithelioid Sarcoma (ES)

Perivascular Epithelioid Cell neoplasm (PEComa)

Disqualifiers

Diagnosis of all other histotypes of soft tissue sarcoma.

Any condition contraindicated with procedures required by the protocol.

Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

Trial design

Design model

Single group

Treatments tested in this trial

  • Patient with Soft Tissue Sarcoma

    Other intervention

    * Tumor specimens will be collected for the study at diagnosis. * A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression. * Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patient with Soft Tissue Sarcoma (Prospective cohort)Other 1 intervention

Trial outcomes

Primary outcomes

1

Metastasis-free survival for patients with localized disease.

Time frame
60 months for each patients
2

Progression-free survival for patients with metastatic disease.

Time frame
60 months for each patients

Secondary outcomes

1

Cancer-Testis Antigens (CTA) expression.

Time frame
60 months for each patients
2

The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.

Time frame
60 months for each patients
3

Overall survival.

Time frame
60 months for each patients

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Claudius Regaud

Lead sponsor

Source ClinicalTrials.gov
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