NCT01577511已完成不适用
Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.
研究概览
简要总结
The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.
详细描述
Secondary objectives include:
- Determine the intrinsic properties essential for the dissemination and chemoresistance of these cells capable of initiating tumors
- Identify a "molecular signature" for potential invasiveness and chemoresistance of cells initiating metastases.
- Describe the evolution of patients during 24 months of follow up and correlations with observed cellular profiles.
- Enrich the tumor bank of the institution.
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
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient with adenocarcinoma-type colorectal cancer:
- •stage III at diagnosis, surgical resection of the primary tumor proposed.
- •stage IV at diagnosis, surgical resection of the primary tumor and possibly of metastases proposed.
- •Stage IV who have already undergone surgical excision of the primary tumor, and for whom metastasectomy is now proposed.
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Patients for whom surgical resection of the primary tumor is not considered as an option
- •PStage IV at diagnosis, but metastasectomy is not considered as an option
- •Patients with positive HIV, Hepatitis B or Hepatitis C serology
研究组 & 干预措施
30 Patients
Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.
Intervention: Samples and follow up
干预措施: Samples and follow up (Biological)
结局指标
主要结局
Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.
时间窗: Baseline (Day 0)
次要结局
- Serology Hepatitis B(baseline; day 0)
- Serology Hepatitis C(baseline; day 0)
- Location of primary tumor(base line; day 0)
- Age at diagnosis(baseline, day 0)
- Resection proposed: yes/no(baseline, day 0)
- Chemotherapy proposed? yes/no(baseline, day 0)
- Objective tumoral response to treatment? yes/no(24 months)
- Metastases from the outset: Yes / No(baseline, day 0)
- Serology HIV(baseline; day 0)
- Number of metastases(24 months)
- Tumor recurrence: yes/no(24 months)
- Vital status(24 months)
- Ability to establish tumor xenografts from injected cells: yes/no.(baseline; Day 0)
- Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells(baseline; day 0)
- Resection performed: yes/no(24 months)
- Number of chemotherapy sessions performed(24 months)
- Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no(baseline; day 0)
- Number of circulating cancer cells per ml blood(baseline; day 0)
- Number of surgeries performed(24 months)
- World Health Organisation Score(24 months)
- Tumor staging(24 months)
研究者
研究点 (1)
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