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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-3. 10. Patient able to participate and willing to give willing to sign a consent form prior to performance of any study-related procedures. 11. Patient affiliated to a Social Health Insurance in France. Who Should NOT Join This Trial: 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 weakened immune system virus (HIV) or known acquired weakened immune system syndrome (AIDS). 4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of willing to sign a consent form or compliance to study procedure. 5. Pregnant or breast-feeding woman. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (20)

Chu Besancon - Site Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Chu Dupuytren
Limoges, France
Centre Leon Berard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Chu de Marseille - Hopital de La Timone
Marseille, France
Centre Antoine Lacassagne
Nice, 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, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France