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

Launched by INSTITUT CLAUDIUS REGAUD · May 27, 2019

Keywords

ClinConnect Summary

The MIRAS Project is a clinical trial focused on studying rare types of soft tissue sarcomas, which are cancers that can develop in muscles, fat, nerves, and other soft tissues in the body. The study aims to gather clinical and biological information about these rare sarcomas by including 500 patients: 400 will be newly recruited, while 100 will be reviewed from previous cases. Eligible participants are adults aged 18 or older with a confirmed diagnosis of specific rare sarcoma subtypes, either localized (not spread) or metastatic (spread to other parts of the body).

If you join this study, you'll receive regular care or participate in a clinical protocol at one of the research centers. The trial will also involve collecting archived tumor samples from your previous diagnosis. Participation means you’ll help researchers understand these rare cancers better, which could lead to improved treatments in the future. It’s important to know that the study is open to all genders, and before joining, you’ll need to provide consent and be part of the French Social Health Insurance system.

Gender

ALL

Eligibility criteria

• 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.