Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcom… (NCT03967834) | Clinical Trial Compass
RecruitingNot Applicable
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
France400 participantsStarted 2021-04-26
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of study entry.
✓. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:
✓. 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.
Exclusion criteria
✕. Diagnosis of all other histotypes of soft tissue sarcoma.
✕
What they're measuring
1
Metastasis-free survival for patients with localized disease.
Timeframe: 60 months for each patients
2
Progression-free survival for patients with metastatic disease.
. 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.