Informations générales (source: ClinicalTrials.gov)
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group (MIRAS)
Interventional
N/A
Institut Claudius Regaud (Voir sur ClinicalTrials)
avril 2021
avril 2031
03 août 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:14 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Pascaline BOUDOU-ROUQUETTE | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Esma SAADA-BOUZID | Contact (sur clinicalTrials) | |||
| Centre Eugene Marquis - Rennes - France | Angélique BRUNOT | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Pascale DUBRAY-LONGERAS | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69008 - Lyon - France | Armelle DUFRESNE | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Loïc LEBELLEC | Contact (sur clinicalTrials) | |||
| Chu Besancon - Site Jean Minjoz - 25000 - Besancon - France | Guillaume MEYNARD | Contact (sur clinicalTrials) | |||
| Chu de Marseille - Hopital de La Timone - Marseille - France | Sébastien SALAS | Contact (sur clinicalTrials) | |||
| Chu Dupuytren - Limoges - France | Valérie LE BRUN-LY | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers - France | Nicolas ISAMBERT | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Maud TOULMONDE | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de Lorraine - 54519 - Vandoeuvre-les-nancy - France | Maria RIOS | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Site Rene Gauducheau - 44805 - Saint-Herblain - France | Emmanuelle BOMPAS | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Strasbourg Europe - Strasbourg - France | Justine GANTZER | Contact (sur clinicalTrials) | |||
| Institut Godinot - Reims - France | SOIBINET-OUDOT Pauline | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13009 - Marseille - France | François BERTUCCI | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse - Oncopole - Toulouse - France | Thibaud VALENTIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.