Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms

Официальное название

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

Обзор

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

Подробное описание

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.

Statistic analysis

The statistic analysis will be performed and reported according to the international guidelines STROBE for the observational studies.

Вмешательства

• Биопрепарат Blood sampling
  Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Following analysis should be performed with * serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...; * plasma for pro
• Процедура Liver biopsy
  An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients. This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time. This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the pa
• Биопрепарат Stool collect
  Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Analysis will be performed for microbiota and metabolism analysis.

Первичные конечные точки

• Overall survival (OS) [Срок оценки: monthly up to 3 months]
• Overall survival (OS) [Срок оценки: yearly up to 10 years]

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Digestive Surgery Department, Ambroise Paré Hospital, APHP — Boulogne-Billancourt

Идентификаторы

NCT: NCT04363983 · 2019-A03330-57

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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