NCT03967834招募中不适用
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Progression-free survival for patients with metastatic disease.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Patient with Soft Tissue Sarcoma (Prospective cohort)
Other
干预措施: Patient with Soft Tissue Sarcoma (Other)
结局指标
主要结局
Progression-free survival for patients with metastatic disease.
时间窗: 60 months for each patients
Metastasis-free survival for patients with localized disease.
时间窗: 60 months for each patients
次要结局
- Overall survival.(60 months for each patients)
- Cancer-Testis Antigens (CTA) expression.(60 months for each patients)
- The rate of patients presenting high-risk CINSARC (Complexity Index in SARComas) signature.(60 months for each patients)
研究者
研究点 (26)
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