Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
Institut Claudius Regaud
400 participants
Apr 26, 2021
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria20
- 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.
Exclusion Criteria6
- 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.
Interventions
* 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)
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NCT03967834