The COLON Study: Colorectal Cancer Cohort

Wageningen University

Status: Active, not recruiting

Conditions: Colorectal Neoplasms Malignant

Treatments: Other: No intervention: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT03191110

NL30446.091.09

CMO number 2009/349 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

2,000 participants in 1 patient group

Colorectal cancer patients

Treatment:

Other: No intervention: observational study