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

Not Applicable

Recruiting

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

• Registration Number: NCT03967834
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2021-04-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with Soft Tissue Sarcoma (Prospective cohort)	Patient with Soft Tissue Sarcoma	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival for patients with metastatic disease.	60 months for each patients
Metastasis-free survival for patients with localized disease.	60 months for each patients

Secondary Outcome Measures

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

Trial Locations

Locations (19)

Chu Besancon - Site Jean Minjoz; 🇫🇷 Besancon, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Chu Dupuytren; 🇫🇷 Limoges, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hôpital Cochin - Site Port-Royal; 🇫🇷 Paris, France

Chu de Marseille - Hopital de La Timone; 🇫🇷 Marseille, France

Institut Curie; 🇫🇷 Paris, France

Chu Poitiers; 🇫🇷 Poitiers, France

Institut Godinot; 🇫🇷 Reims, France

Institut de Cancerologie de L'Ouest - Site Rene Gauducheau; 🇫🇷 Saint-Herblain, France

Institut de Cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut de Cancerologie de Lorraine; 🇫🇷 Vandoeuvre-les-nancy, France