The COLON Study: Colorectal Cancer: Longitudinal, Observational Study on Nutritional and Lifestyle Factors That May Influence Colorectal Tumour Recurrence, Survival and Quality of Life
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasms Malignant
- Sponsor
- Wageningen University
- Enrollment
- 2000
- Locations
- 11
- Primary Endpoint
- Cancer recurrence
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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.
Investigators
Ellen Kampman
prof. dr. ir. Ellen Kampman
Wageningen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cancer recurrence
Time Frame: An average follow-up of at least 5 years
Cancer recurrence
Quality of life (EORTC QLQ-C30)
Time Frame: An average follow-up of at least 5 years
Quality of life
Survival
Time Frame: An average follow-up of at least 5 years
Overall survival
Secondary Outcomes
- 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)