跳至主要内容
临床试验/NCT05404321
NCT05404321招募中不适用

Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment

Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2023年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
163
试验地点
1
主要终点
Rate of establishment of exploitable organoids tumor

研究概览

简要总结

Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix.

These principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1/2 mutant signature, highlighting the potential of these models to predict patient response to these treatments.

Furthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.

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
Female
接受健康志愿者

入选标准

  • Patient over 18 years of age
  • Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy
  • Patient affiliated to a social security system
  • Proficiency in French language,
  • Patient having signed the consent to participate in the study.

排除标准

  • Pregnant women
  • Persons deprived of liberty or under guardianship (including curatorship)
  • History of any other clinically active malignancy in the last 5 years prior to inclusion

研究组 & 干预措施

Patient with early stage triple negative breast cancer

干预措施: Establishment of ex vivo breast cancer organoid models (Other)

结局指标

主要结局

Rate of establishment of exploitable organoids tumor

时间窗: 4 years

次要结局

未报告次要终点

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (1)

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