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临床试验/NCT07385612
NCT07385612尚未招募不适用

RESEARCH ON FACTORS OF RESISTANCE TO CHEMOTHERAPY AND INNOVATIVE THERAPIES IN MATURE B-CELL LYMPHOIDS

Nantes University Hospital4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
4
主要终点
Characterization of the tumor

研究概览

简要总结

In order to promote translational research on the molecular pathways involved in resistance to treatments for mantle cell lymphoma (MCL), the clinical haematology department of the University Hospital Center (CHU) of Nantes has established, since 2016, the REFRACT-LyMa (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma) cohort-biocollection of blood and bone marrow samples from patients with MCL. Thanks to the close collaborations with team 11 of the Integrated Cancer Research and Immunology Center Nantes Angers (CRCI²NA), which specializes in studying the molecular pathways involved in resistance to treatments for hematological cancers, we wish to broaden the scope of research to other B-cell non-Hodgkin lymphomas (B-NHL). That is why today the REFRACT-LyMa cohort-biocollection aims to expand to malignant hematopathies involving mature B cells (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies).

详细描述

A collection of tumor samples collected before the initiation of any new line of treatment as well as after any relapse/progression, is essential to identify the factors of response or resistance to a given therapy. To support the translational research projects on MCL in collaboration with team 11 of CRCI²NA, the clinical hematology department of the CHU of Nantes established, in 2016, the prospective multicentric (five centers: Nantes, La Roche-sur-Yon, Vannes, Saint-Nazaire and Poitiers) cohort-biocollection REFRACT-LyMA (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma), with the aim of constituting a cohort of patients integrating clinico-biological data linked to a biocollection of blood, bone marrow, lymphadenopathy, pleural fluid and ascites samples. Thanks to primary cells from patients derived from the biocollection, the REFRACT-LyMa cohort has highlighted molecular aberrations and genomic instability of tumor cells leading to the emergence of heterogeneous subclones at the base of the main mechanism of chemoresistance, which can be used as predictive factors of response/sensitivity to treatments in MCL. However, the therapies used in MCL are also applicable to other malignant hematopathies. That is why we wish to expand our cohort-biocollection to the Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies (REFRACT-LyMa). Although the patients with MCL already included in the cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma" will continue to be followed retrospectively and new MCL patients will be included prospectively, not all new patients with B-NHL will be automatically included in the new cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B Lymphoid Hemopathies". The choice will depend on the pathology subject to the ongoing translational research studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient affected by B-NHL (at diagnosis or relapse).
  • Patient who has signed the consent form.
  • Patient affiliated with a social security system.

排除标准

  • Minor patients.
  • Adults under guardianship.
  • Protected persons.

研究组 & 干预措施

Newly diagnosed or relapsed NHL-B patients (based on ongoing translational research studies)

Clinical data collection and blood, bone marrow, lymphadenopathy as well as pleural fluid and ascites sampling at the time of inclusion (for diagnosis or relapse) and at each relapse/progression.

结局指标

主要结局

Characterization of the tumor

时间窗: 10 years

Characterization of the tumor and its microenvironment in B-NHL in order to develop preclinical models of ex vivo culture and genetic modifications of primary B-NHL cells.

次要结局

  • Preclinical model(10 years)
  • Data analysis(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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