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

February 9, 2026 updated by: Institut Claudius Regaud

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Chu Besancon - Site Jean Minjoz
        • Contact:
      • Bordeaux, France
      • Clermont-Ferrand, France, 63011
      • Dijon, France
        • Not yet recruiting
        • Centre Georges François Leclerc
        • Contact:
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
      • Limoges, France
      • Lyon, France, 69008
      • Marseille, France
        • Recruiting
        • CHU de Marseille - Hôpital de la Timone
        • Contact:
      • Marseille, France, 13009
        • Withdrawn
        • Institut Paoli-Calmettes
      • Nice, France, 06189
      • Paris, France
      • Paris, France
        • Recruiting
        • Hôpital Cochin - Site Port-Royal
        • Contact:
      • Poitiers, France
      • Reims, France
      • Rennes, France
      • Saint-Herblain, France, 44805
        • Withdrawn
        • Institut de Cancérologie de l'Ouest - Site René Gauducheau
      • Strasbourg, France
      • Toulouse, France
        • Recruiting
        • Institut Universitaire du Cancer Toulouse - Oncopole
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
      • Villejuif, France, 94805
        • Withdrawn
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years at the time of study entry.

  2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:

    • Clear Cell Sarcoma (CCS)
    • Epithelioid Sarcoma (ES)
    • Perivascular Epithelioid Cell neoplasm (PEComa)
    • Desmoplastic Small Round Cell Tumours (DSRCT)
    • Malignant Solitary Fibrous Tumours (mSFT)
    • Alveolar Soft Part Sarcoma (ASPS)
    • Epithelioid Hemangioendothelioma (EH)
    • Low-Grade Fibromyxoid Sarcoma (LGFS)
    • Sclerosing Epithelioid Fibrosarcoma (SEF).
  3. Localized/locally advanced or metastatic disease.
  4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
  5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
  6. Patient followed in the center within a standard of care procedure or clinical trial.
  7. Archived tumor specimen at initial diagnosis available (before treatment initiation).
  8. Evaluable disease (measurable as per RECIST 1.1) or not.
  9. ECOG Performance status 0-3.
  10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
  11. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. Diagnosis of all other histotypes of soft tissue sarcoma.
  2. Any condition contraindicated with procedures required by the protocol.
  3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  4. 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.
  5. Pregnant or breast-feeding woman.
  6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient with Soft Tissue Sarcoma (Prospective cohort)
Other: Patient with Soft Tissue Sarcoma
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metastasis-free survival for patients with localized disease.
Time Frame: 60 months for each patients
60 months for each patients
Progression-free survival for patients with metastatic disease.
Time Frame: 60 months for each patients
60 months for each patients

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer-Testis Antigens (CTA) expression.
Time Frame: 60 months for each patients
60 months for each patients
The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.
Time Frame: 60 months for each patients
60 months for each patients
Overall survival.
Time Frame: 60 months for each patients
60 months for each patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 SARC 04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Soft Tissue Sarcoma

Clinical Trials on Patient with Soft Tissue Sarcoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe