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临床试验/NCT04363983
NCT04363983招募中不适用

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 6,300 人开始时间: 2021年1月13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
入组人数
6,300
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).

详细描述

The study aims to explore relationship between the molecular subgroups (DNA and RNA analysis), tumor microenvironment, host (immunity system, premetastatic niche, microbiota, metabolism) and survival (prognostic value), response (predictive value) and tolerance (toxicities) to conventional treatments or immunotherapies in digestive cancers, in particular, in colorectal cancer and pancreaticobiliary cancer.

This is a prognostic monocentric study which includes 2 parts:

  • one retrospective observational cohort for which 150 eligible patients (who have being diagnosed between 1998 to 2020) will be entered in the cohort per year during 22 years targeting 3300 patients and
  • one prospective interventional cohort in which 3000 patients (diagnosis will be done between 2020-2030) will be enrolled during 10 years. 10 years of follow-up for all patients. This cohort is non comparative, non randomized, non control.

The enrollment will last 10 years in Digestive Surgery Department, Ambroise Paré Hospital, APHP.

There is any change in management of patients' care who will participate to the study, all of the treatment modalities (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, intra-arterial treatments and supportive care) are possible and choice of treatment will be made by investigator physician, after multidisciplinary meeting validation, and according to referential and recommendations of practice in department.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • •Carcinoma of colorectal, pancreatic, biliary tract or gastro-oesophageal, or neuroendocrine digestive tumors with cytologically or histologically proven, regardless of the stage;
  • •Diagnosis between 1998 and 2030;
  • •Be >/= 18 years;
  • •Have obtained signed informed consent (exemption for dead patients);
  • •Affiliated to the French social security - welfare system in France (CMU included).

排除标准

  • •Patient under tutoraship or curatorship;
  • •Foreign patient under AME schema, a medical help from the state in France;
  • •Pregnant or breastfeeding women (for prospective study);
  • •Any clinical, psychological or social reason which should influence patient compliance with protocol, according to investigator;
  • •Patient refusal.

研究组 & 干预措施

Advanced pancreatic cancer

Active Comparator

干预措施: Blood sampling (Biological)

Advanced pancreatic cancer

Active Comparator

干预措施: Stool collect (Biological)

Located/resected biliary tract cancer

Active Comparator

干预措施: Blood sampling (Biological)

Located/resected biliary tract cancer

Active Comparator

干预措施: Liver biopsy (Procedure)

Located/resected biliary tract cancer

Active Comparator

干预措施: Stool collect (Biological)

Advanced biliary tract cancer

Active Comparator

干预措施: Blood sampling (Biological)

Advanced biliary tract cancer

Active Comparator

干预措施: Stool collect (Biological)

Located/resected gastroesophageal cancer

Active Comparator

干预措施: Blood sampling (Biological)

Located/resected gastroesophageal cancer

Active Comparator

干预措施: Liver biopsy (Procedure)

Located/resected gastroesophageal cancer

Active Comparator

干预措施: Stool collect (Biological)

Advanced gastroesophageal cancer

Active Comparator

干预措施: Blood sampling (Biological)

Advanced gastroesophageal cancer

Active Comparator

干预措施: Stool collect (Biological)

Located/resected neuroendocrine cancer

Active Comparator

干预措施: Blood sampling (Biological)

Located/resected neuroendocrine cancer

Active Comparator

干预措施: Liver biopsy (Procedure)

Located/resected neuroendocrine cancer

Active Comparator

干预措施: Stool collect (Biological)

Advanced neuroendocrine cancer

Active Comparator

干预措施: Blood sampling (Biological)

Advanced neuroendocrine cancer

Active Comparator

干预措施: Stool collect (Biological)

Located/resected colorectal cancer

Active Comparator

干预措施: Blood sampling (Biological)

Located/resected colorectal cancer

Active Comparator

干预措施: Liver biopsy (Procedure)

Located/resected colorectal cancer

Active Comparator

干预措施: Stool collect (Biological)

Advanced colorectal cancer

Active Comparator

干预措施: Blood sampling (Biological)

Advanced colorectal cancer

Active Comparator

干预措施: Stool collect (Biological)

Located/resected pancreatic cancer

Active Comparator

干预措施: Blood sampling (Biological)

Located/resected pancreatic cancer

Active Comparator

干预措施: Liver biopsy (Procedure)

Located/resected pancreatic cancer

Active Comparator

干预措施: Stool collect (Biological)

结局指标

主要结局

Overall survival (OS)

时间窗: yearly up to 10 years

The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).

Overall survival (OS)

时间窗: monthly up to 3 months

The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason).

次要结局

  • Survival without disease (SWD)(at month 1, 2 and 3, then yearly up to 10 years)
  • Survival without progression (SWP)(at month 1, 2 and 3, then yearly up to 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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