The COLON Study: Colorectal Cancer Cohort
- Conditions
- Colorectal Neoplasms Malignant
- Registration Number
- NCT03191110
- Lead Sponsor
- Wageningen University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Patients newly diagnosed with colorectal cancer in one of the participating hospitals
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cancer recurrence An average follow-up of at least 5 years Cancer recurrence
Quality of life (EORTC QLQ-C30) An average follow-up of at least 5 years Quality of life
Survival An average follow-up of at least 5 years Overall survival
- Secondary Outcome Measures
Name Time Method 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 Stool samples
Chemotherapy-induced toxicity (QLQ-CIPN20) 12 months after diagnosis Chemotherapy-induced peripheral neuropathy
Trial Locations
- Locations (11)
Ziekenhuisgroep Twente
🇳🇱Almelo, Netherlands
Gelre Hospital
🇳🇱Apeldoorn, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Slingeland Hospital
🇳🇱Doetinchem, Netherlands
Hospital Gelderse Vallei
🇳🇱Ede, Netherlands
Admiraal De Ruyter Hospital
🇳🇱Goes/Vlissingen, Netherlands
Martini Hospital
🇳🇱Groningen, Netherlands
Canisius Wilhelmina Hospital
🇳🇱Nijmegen, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Bernhoven Hospital
🇳🇱Oss, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands