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

  • STATUS
    Recruiting
  • End date
    Sep 7, 2022
  • participants needed
    400
  • sponsor
    Institut Claudius Regaud
Updated on 10 October 2021
desmoplastic
fibrosarcoma
soft tissue sarcoma
alveolar soft part sarcoma
epithelioid sarcoma

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).

Details
Condition Alveolar Soft Part Sarcoma, Connective and Soft Tissue Neoplasm, pecoma, Epithelioid hemangioendothelioma, Desmoplastic Small Round Cell Tumor, Clear cell sarcoma, Sarcoma, All Solid Tumors, Solid Tumors, Low Grade Fibromyxoid Sarcoma, Sclerosing Epithelioid Fibrosarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, sarcomas, soft tissue sarcomas, epithelioid sarcoma, Malignant Solitary Fibrous Tumors
Treatment Patient with Soft Tissue Sarcoma
Clinical Study IdentifierNCT03967834
SponsorInstitut Claudius Regaud
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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