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临床试验/NCT03191110
NCT03191110进行中(未招募)不适用

The COLON Study: Colorectal Cancer: Longitudinal, Observational Study on Nutritional and Lifestyle Factors That May Influence Colorectal Tumour Recurrence, Survival and Quality of Life

Wageningen University11 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,000
试验地点
11
主要终点
Cancer recurrence

研究概览

简要总结

The main aim of this observational, prospective cohort study is to assess associations of diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of life.

详细描述

The COLON study is a multi-centre prospective cohort study among incident colorectal cancer patients recruited from 12 hospitals in the Netherlands. Patients with colorectal cancer are invited upon diagnosis. Upon recruitment, after 6 months, 2 years and 5 years, patients fill out food-frequency questionnaires; questionnaires about dietary supplement use, physical activity, weight, height, and quality of life; and donate blood samples. Diagnostic CT-scans are collected to assess cross-sectional areas of skeletal muscle, subcutaneous fat, visceral fat and intermuscular fat, and to assess muscle attenuation. Blood samples are biobanked to facilitate future analyse of biomarkers, nutrients, DNA etc. Analysis of serum 25-hydroxy vitamin D levels, B-vitamins and metabolomic profiles are scheduled. A subgroup of patients with colon cancer is asked to provide faecal samples before and at several time points after colon resection to study changes in gut microbiota during treatment. For all patients, information on vital status is retrieved by linkage with national registries. Information on clinical characteristics, including treatment-related toxicity and co-morbidity data, is gathered from linkage with the Netherlands Cancer Registry and with hospital databases or medical records. Hazard ratios will be calculated for dietary and lifestyle factors at diagnosis in relation to recurrence and survival. Repeated measures analyses will be performed to assess changes over time in dietary and other factors in relation to recurrence and survival.

The aim is to recruit at least 2000 patients with available data and blood samples.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients newly diagnosed with colorectal cancer in one of the participating hospitals

排除标准

  • Non-Dutch speaking
  • A history of colorectal cancer or (partial) bowel resection
  • Chronic inflammatory bowel disease
  • Hereditary colorectal cancer syndromes (Lynch syndrome, FAP, Peutz-Jegher)
  • Dementia or another mental condition that makes it impossible to fill out questionnaires

结局指标

主要结局

Cancer recurrence

时间窗: An average follow-up of at least 5 years

Cancer recurrence

Quality of life (EORTC QLQ-C30)

时间窗: An average follow-up of at least 5 years

Quality of life

Survival

时间窗: An average follow-up of at least 5 years

Overall survival

次要结局

  • Co-morbidities(An average follow-up of at least 5 years)
  • Microbiota composition based on 16S rRNA profiling(At diagnosis and 6, 12 and 35 weeks after resection)
  • Chemotherapy-induced toxicity (QLQ-CIPN20)(12 months after diagnosis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Kampman

prof. dr. ir. Ellen Kampman

Wageningen University

研究点 (11)

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