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Clinical Trials in France / NCT03967834
Recruiting Not applicable

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

NCT03967834 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-04-26
Last updated
2026-02-10

Condition(s) studied

Soft Tissue SarcomaClear Cell SarcomaEpithelioid SarcomaPerivascular Epithelioid Cell NeoplasmsDesmoplastic Small Round Cell TumorMalignant Solitary Fibrous TumorsAlveolar Soft Part SarcomaEpithelioid HemangioendotheliomaLow Grade Fibromyxoid SarcomaSclerosing Epithelioid Fibrosarcoma

Investigational drug(s) / intervention(s)

Patient with Soft Tissue Sarcoma

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 center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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). 3. Localized/locally advanced or metastatic disease. 4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision). 5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion. 6. Patient followed in the center within a standard of care procedure or clinical trial. 7. Archived tumor specimen at initial diagnosis available (before treatment initiation). 8. Evaluable disease (measurable as per RECIST 1.1) or not. 9. ECOG Performance status 0-3. 10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures. 11. Patient affiliated to a Social Health Insurance in France. 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 human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 4. 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. 5. Pregnant or breast-feeding woman. 6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Chu Besancon - Site Jean Minjoz Besançon France Recruiting
Institut Bergonié Bordeaux France Recruiting
Centre Jean Perrin Clermont-Ferrand France Recruiting
Centre Georges François Leclerc Dijon France Not Yet Recruiting
Centre Oscar Lambret Lille France Recruiting
Chu Dupuytren Limoges France Recruiting
Centre Leon Berard Lyon France Recruiting
Institut Paoli-Calmettes Marseille France Withdrawn
Chu de Marseille - Hopital de La Timone Marseille France Recruiting
Centre Antoine Lacassagne Nice France Recruiting
Hôpital Cochin - Site Port-Royal Paris France Recruiting
Institut Curie Paris France Recruiting
Chu Poitiers Poitiers France Recruiting
Institut Godinot Reims France Recruiting
Centre Eugene Marquis Rennes France Recruiting
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau Saint-Herblain France Withdrawn
Hôpitaux Universitaires de Strasbourg Strasbourg France Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Recruiting
Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy France Recruiting
Institut Gustave Roussy Villejuif France Withdrawn

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03967834 on ClinicalTrials.gov ↗ ← All trials in France