NCT03015038已完成不适用
Etude de la réponse Immunitaire Dans l'adénocarcinome Colique
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Immune cells trafficking
研究概览
简要总结
Duration of each part of the study per patient:
- Screening: From 1 to 4 weeks
- Sampling period (blood and tissue): 1 day
- Follow-up by patient: 60 months
- Total study duration by patient: 84 months
- Total inclusion duration: 24 months
- Total Follow-up duration: 60 months
- Total study duration: 84 months
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
- •Patients aged 18 or more.
- •Affiliation to a social security scheme
- •Diagnosis of a colon adenocarcinoma.
- •Patient have signed and dated consent of the study before undertaking procedures related to the study.
排除标准
- •Patients under guardianship / curatorship
- •Following Situations
- •Persons unable to understand, read and / or sign an informed consent
- •Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
- •Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
- •No affiliation to a social security scheme, a universal medical coverage or any similar plan.
- •Pregnant or lactating women.
- •Patients with HIV seropositivity.
- •Rectal tumor location.
结局指标
主要结局
Immune cells trafficking
时间窗: Day 0
Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).
次要结局
- Infiltration of leucocytes in tumor tissue(Day 0)
- Safety (Number of adverse events, ECOG status)(After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60))
研究者
研究点 (1)
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