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

Last updated: August 1, 2024
Sponsor: Institut Claudius Regaud
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Sarcoma

Sarcoma (Pediatric)

Treatment

Patient with Soft Tissue Sarcoma

Clinical Study ID

NCT03967834
19 SARC 04
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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).

  1. Localized/locally advanced or metastatic disease.

  2. In case of localized disease, treatment must not have been yet initiated beforeinclusion (except surgical excision).

  3. In case of metastatic disease, project of new line of systemic treatment must havebeen decided before inclusion.

  4. Patient followed in the center within a standard of care procedure or clinicaltrial.

  5. Archived tumor specimen at initial diagnosis available (before treatmentinitiation).

  6. Evaluable disease (measurable as per RECIST 1.1) or not.

  7. ECOG Performance status 0-3.

  8. Patient able to participate and willing to give informed consent prior toperformance of any study-related procedures.

  9. Patient affiliated to a Social Health Insurance in France.

Exclusion

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 humanimmunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

  4. Any psychological, familial, geographic or social situation, according to thejudgment of investigator, potentially preventing the provision of informed consentor 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 isunder guardianship.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Patient with Soft Tissue Sarcoma
Phase:
Study Start date:
April 26, 2021
Estimated Completion Date:
April 30, 2031

Connect with a study center

  • Chu Besancon - Site Jean Minjoz

    Besancon, 25000
    France

    Active - Recruiting

  • Institut Bergonié

    Bordeaux,
    France

    Active - Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59020
    France

    Active - Recruiting

  • Chu Dupuytren

    Limoges,
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • Chu de Marseille - Hopital de La Timone

    Marseille,
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

  • Hôpital Cochin - Site Port-Royal

    Paris,
    France

    Active - Recruiting

  • Institut Curie

    Paris,
    France

    Active - Recruiting

  • Chu Poitiers

    Poitiers,
    France

    Active - Recruiting

  • Institut Godinot

    Reims,
    France

    Active - Recruiting

  • Centre Eugene Marquis

    Rennes,
    France

    Active - Recruiting

  • Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

    Saint-Herblain, 44805
    France

    Site Not Available

  • Institut de Cancérologie Strasbourg Europe

    Strasbourg,
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse,
    France

    Active - Recruiting

  • Institut de Cancerologie de Lorraine

    Vandoeuvre-les-nancy, 54519
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.