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

Sponsor
Institut Claudius Regaud
Study ID
NCT03967834
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient with Soft Tissue Sarcoma — OTHER
    * 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 center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years.

Study Details

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).

Key Dates

First listed
May 30, 2019
Start date
Apr 26, 2021
Status verified
Feb 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Patient with Soft Tissue Sarcoma (Prospective cohort)

Primary Outcome Measure

Metastasis-free survival for patients with localized disease. [ Time Frame: 60 months for each patients ]

Central Contacts

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