NCT01966081已完成不适用
Consumption of Fatty Acids, Metabolism of Adipose Tissue and Risk of Colorectal Cancer: AGARIC Case Control Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 5
- 主要终点
- Measure of polyunsaturated fatty acids in adipose tissue lipids.
研究概览
简要总结
The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 45 years
- •with a first recently-diagnosed colorectal cancer
- •due to undergo elective surgical resection with curative intent (in practice, stage I, II, III or IV if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: CHU de Dijon, CHU de Nancy, CHU de Strasbourg, CHU de Reims et CHU and Besançon.
- •who have given their informed consent
- •Patients aged ≥ 45 years
- •due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia …)
- •matched for abdominal site with cases for age (± 3 years), sex and hospital
- •Who have given their informed consent
排除标准
- •pre-operative anticancer treatment (chemo or radiotherapy)
- •existence of visceral metastases except a single hepatic nodule resected with curative intent
- •familial adenomatous polyposis and HNPCC syndrome (when suspected: inclusion after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of DNA mismatch repair proteins.
- •known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
- •personal history (recent or not) of colorectal cancer
- •emergency treatment for the presenting complication (perforation, occlusion…)
- •significant modification in dietary habits during the previous three months
- •other evolving neoplastic disease
- •psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
- •pregnant or breast-feeding women
- •personal history of cancer or adenomatous colorectal polyps,
- •emergency intervention
- •known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
- •personal history (recent or not) of colorectal cancer
- •emergency treatment for the presenting complication (perforation, occlusion…)
- •significant modification in dietary habits during the previous three months
- •evolving neoplastic disease
- •psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
- •pregnant or breast-feeding women
研究组 & 干预措施
controls
Other
干预措施: Blood sample (Other)
controls
Other
干预措施: tissue samples from abdominal subcutaneous adipose (Other)
Cases
Other
干预措施: Blood sample (Other)
Cases
Other
干预措施: tissue samples from abdominal subcutaneous adipose (Other)
结局指标
主要结局
Measure of polyunsaturated fatty acids in adipose tissue lipids.
时间窗: baselines
次要结局
未报告次要终点
研究者
研究点 (5)
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