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Recruiting NCT03967834

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

No phase Interventional Soft Tissue Sarcoma Clear Cell Sarcoma Epithelioid Sarcoma Perivascular Epithelioid Cell Neoplasms

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient with Soft Tissue Sarcoma.
Who it may be relevant to
Registry conditions: Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Other Patient with Soft Tissue Sarcoma
    * Tumor specimens will be collected for the study at diagnosis. * A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression. * Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the cente

Primary outcome measures

  • Metastasis-free survival for patients with localized disease. [Time frame: 60 months for each patients]
  • Progression-free survival for patients with metastatic disease. [Time frame: 60 months for each patients]
Secondary outcome measures (3)
  • Cancer-Testis Antigens (CTA) expression. [Time frame: 60 months for each patients]
  • The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature. [Time frame: 60 months for each patients]
  • Overall survival. [Time frame: 60 months for each patients]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 20 centers
  • Chu Besancon - Site Jean Minjoz — Besançon
  • Institut Bergonié — Bordeaux
  • Centre Jean Perrin — Clermont-Ferrand
  • Centre Georges François Leclerc — Dijon
  • Centre Oscar Lambret — Lille
  • Chu Dupuytren — Limoges
  • Centre Leon Berard — Lyon
  • Institut Paoli-Calmettes — Marseille
  • … and 12 more centers

Identifiers

NCT: NCT03967834 · 19 SARC 04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗