Characterizing rare soft tissue sarcomas
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
NA · Institut Claudius Regaud · NCT03967834
This study is trying to learn more about rare types of soft tissue sarcomas by collecting detailed information from 400 patients to help improve treatment options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud (other) |
| Locations | 20 sites (Besançon and 19 other locations) |
| Trial ID | NCT03967834 on ClinicalTrials.gov |
What this trial studies
This project involves a comprehensive clinical and biological characterization of rare subtypes of soft tissue sarcomas through a prospective cohort of 400 patients and a retrospective analysis of 100 cases. Patients will be identified from various centers either during routine care or through clinical study protocols. The study aims to gather detailed information on these rare sarcoma subtypes to improve understanding and treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with specific rare sarcoma subtypes and either localized or metastatic disease.
Not a fit: Patients with sarcoma subtypes not included in the study or those who have already initiated treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better-targeted therapies and improved outcomes for patients with rare soft tissue sarcomas.
How similar studies have performed: Other studies focusing on the characterization of rare sarcomas have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Besançon and 19 other locations
- 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)
Study contacts
- Study coordinator: Thibaud VALENTIN
- Email: Valentin.Thibaud@iuct-oncopole.fr
- Phone: +33 (0)5 31 15 51 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Soft Tissue Sarcoma, Clear Cell Sarcoma, Epithelioid Sarcoma, Perivascular Epithelioid Cell Neoplasms, Desmoplastic Small Round Cell Tumor, Malignant Solitary Fibrous Tumors, Alveolar Soft Part Sarcoma, Epithelioid Hemangioendothelioma