Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03967834

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at the time of study entry.
  • 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).
  • Localized/locally advanced or metastatic disease.
  • In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
  • In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
  • Patient followed in the center within a standard of care procedure or clinical trial.
  • Archived tumor specimen at initial diagnosis available (before treatment initiation).
  • Evaluable disease (measurable as per RECIST 1.1) or not.
  • ECOG Performance status 0-3.
  • Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
  • Patient affiliated to a Social Health Insurance in France.

Exclusion criteria

  • 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.
  • Pregnant or breast-feeding woman.
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Treatment and study plan

Patient with Soft Tissue Sarcoma

Other
  • 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric CHIBON

CONTACT

[email protected]

+33 (0)5 82 74 17 65

Thibaud VALENTIN

CONTACT

[email protected]

+33 (0)5 31 15 51 70

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MIRAS

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
May 30, 2019
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.