Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
MIRAS
1 other identifier
interventional
400
1 country
20
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
February 10, 2026
February 1, 2026
9.9 years
May 27, 2019
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Metastasis-free survival for patients with localized disease.
60 months for each patients
Progression-free survival for patients with metastatic disease.
60 months for each patients
Secondary Outcomes (3)
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
Overall survival.
60 months for each patients
Study Arms (1)
Patient with Soft Tissue Sarcoma (Prospective cohort)
OTHERInterventions
* 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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Chu Besancon - Site Jean Minjoz
Besançon, 25000, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, 59020, France
Chu Dupuytren
Limoges, France
Centre Leon Berard
Lyon, 69008, France
Institut Paoli-Calmettes
Marseille, 13009, France
Chu de Marseille - Hopital de La Timone
Marseille, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Cochin - Site Port-Royal
Paris, France
Institut Curie
Paris, France
Chu Poitiers
Poitiers, France
Institut Godinot
Reims, France
Centre Eugene Marquis
Rennes, France
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain, 44805, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
May 30, 2019
Study Start
April 26, 2021
Primary Completion (Estimated)
April 1, 2031
Study Completion (Estimated)
April 1, 2031
Last Updated
February 10, 2026
Record last verified: 2026-02