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

Institut Claudius Regaud

Status: Enrolling

Conditions: Sclerosing Epithelioid Fibrosarcoma; Perivascular Epithelioid Cell Neoplasms; Desmoplastic Small Round Cell Tumor; Low Grade Fibromyxoid Sarcoma; Soft Tissue Sarcoma; Epithelioid Sarcoma; Clear Cell Sarcoma; Malignant Solitary Fibrous Tumors; Alveolar Soft Part Sarcoma; Epithelioid Hemangioendothelioma

Treatments: Other: Patient with Soft Tissue Sarcoma

Study type: Interventional

Funder types: Other

Identifiers

NCT03967834

19 SARC 04

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Patient with Soft Tissue Sarcoma (Prospective cohort)

Other group

Treatment:

Other: Patient with Soft Tissue Sarcoma