Etude : MIRAS /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : MIRAS

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

Spécialité : Tissu mésothélial et tissus mous
Localisation : C49 - Tumeur maligne du tissu conjonctif et des autres tissus mous
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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).

STUDY DESIGN:
- 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.

Phase : NA

Stade : Localisé à Métastatique

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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.
- In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
- In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
- 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.
- ECOG Performance status 0-3.
- Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
- Patient affiliated to a Social Health Insurance in France.

Critères de non-inclusion : - 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03967834
Promoteur :
Institut Claudius Regaud
Type de sponsor : Institutionnel
31100 TOULOUSE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Loïc LEBELLEC

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 29/09/2021