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

Обзор

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).

Вмешательства

• Другое 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 cente

Первичные конечные точки

• Metastasis-free survival for patients with localized disease. [Срок оценки: 60 months for each patients]
• Progression-free survival for patients with metastatic disease. [Срок оценки: 60 months for each patients]

Вторичные конечные точки (3)

• Cancer-Testis Antigens (CTA) expression. [Срок оценки: 60 months for each patients]
• The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature. [Срок оценки: 60 months for each patients]
• Overall survival. [Срок оценки: 60 months for each patients]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 20 центров

• Chu Besancon - Site Jean Minjoz — Besançon
• Institut Bergonié — Bordeaux
• Centre Jean Perrin — Clermont-Ferrand
• Centre Georges François Leclerc — Dijon
• Centre Oscar Lambret — Lille
• Chu Dupuytren — Limoges
• Centre Leon Berard — Lyon
• Institut Paoli-Calmettes — Marseille
• … и ещё 12 центров

Идентификаторы

NCT: NCT03967834 · 19 SARC 04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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