Clinical trial NCT03191110: The COLON Study: Colorectal Cancer Cohort
Official title: The COLON Study: Colorectal Cancer: Longitudinal, Observational Study on Nutritional and Lifestyle Factors That May Influence Colorectal Tumour Recurrence, Survival and Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Neoplasms Malignant
Keywords: COLON
colorectal cancer
nutrition
lifestyle
survival
recurrence
quality of life
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Wereld Kanker Onderzoek Fonds
name: Funding: World Cancer Research Fund International
name: Funding: ERA-NET on Translational Cancer Research (TRANSCAN)
First posted: 2017-06-19
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women of all ages, who were newly diagnosed with colorectal cancer (ICD codes C18-20) in any stage of the disease in one of the participating hospitals.

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.

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

Primary outcomes:
measure: Survival
timeFrame: An average follow-up of at least 5 years
measure: Cancer recurrence
timeFrame: An average follow-up of at least 5 years
measure: Quality of life (EORTC QLQ-C30)
timeFrame: An average follow-up of at least 5 years
Secondary outcomes:
measure: Chemotherapy-induced toxicity (QLQ-CIPN20)
timeFrame: 12 months after diagnosis
measure: Microbiota composition based on 16S rRNA profiling
timeFrame: At diagnosis and 6, 12 and 35 weeks after resection
measure: Co-morbidities
timeFrame: An average follow-up of at least 5 years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei
city: Goes/Vlissingen
country: Netherlands
facility: Admiraal De Ruyter Hospital
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Oss
country: Netherlands
facility: Bernhoven Hospital
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Wageningen University
name: Ellen Kampman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkels RM, Heine-Broring RC, van Zutphen M, van Harten-Gerritsen S, Kok DE, van Duijnhoven FJ, Kampman E. The COLON study: Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life. BMC Cancer. 2014 May 27;14:374. doi: 10.1186/1471-2407-14-374.
citation: Geijsen AJMR, Kok DE, van Zutphen M, Keski-Rahkonen P, Achaintre D, Gicquiau A, Gsur A, Kruyt FM, Ulrich CM, Weijenberg MP, de Wilt JHW, Wesselink E, Scalbert A, Kampman E, van Duijnhoven FJB. Diet quality indices and dietary patterns are associated with plasma metabolites in colorectal cancer patients. Eur J Nutr. 2021 Sep;60(6):3171-3184. doi: 10.1007/s00394-021-02488-1. Epub 2021 Feb 5.
citation: Wesselink E, Kok DE, de Wilt JHW, Bours MJL, van Zutphen M, Keulen ETP, Kruyt FM, Breukink SO, Kouwenhoven EA, van den Ouweland J, Weijenberg MP, Kampman E, van Duijnhoven FJB. Sufficient 25-Hydroxyvitamin D Levels 2 Years after Colorectal Cancer Diagnosis are Associated with a Lower Risk of All-cause Mortality. Cancer Epidemiol Biomarkers Prev. 2021 Apr;30(4):765-773. doi: 10.1158/1055-9965.EPI-20-1388. Epub 2021 Feb 2.
citation: Wesselink E, Staritsky LE, van Zutphen M, Geijsen AJMR, Kok DE, Kruyt F, Veenstra RP, Spillenaar Bilgen EJ, Kouwenhoven EA, de Wilt JHW, Kampman E, van Duijnhoven FJB. The association between the adapted dietary inflammatory index and colorectal cancer recurrence and all-cause mortality. Clin Nutr. 2021 Jun;40(6):4436-4443. doi: 10.1016/j.clnu.2021.01.004. Epub 2021 Jan 11.
citation: van Baar H, Bours MJL, Beijer S, van Zutphen M, van Duijnhoven FJB, Kok DE, Wesselink E, de Wilt JHW, Kampman E, Winkels RM. Body composition and its association with fatigue in the first 2 years after colorectal cancer diagnosis. J Cancer Surviv. 2021 Aug;15(4):597-606. doi: 10.1007/s11764-020-00953-0. Epub 2020 Oct 17.
citation: Wesselink E, Kok DE, Bours MJL, de Wilt JHW, van Baar H, van Zutphen M, Geijsen AMJR, Keulen ETP, Hansson BME, van den Ouweland J, Witkamp RF, Weijenberg MP, Kampman E, van Duijnhoven FJB. Vitamin D, magnesium, calcium, and their interaction in relation to colorectal cancer recurrence and all-cause mortality. Am J Clin Nutr. 2020 May 1;111(5):1007-1017. doi: 10.1093/ajcn/nqaa049.
citation: Wesselink E, Bours MJL, de Wilt JHW, Aquarius M, Breukink SO, Hansson B, Keulen ETP, Kok DE, van den Ouweland J, van Roekel EH, Snellen M, Winkels R, Witkamp RF, van Zutphen M, Weijenberg MP, Kampman E, van Duijnhoven FJB. Chemotherapy and vitamin D supplement use are determinants of serum 25-hydroxyvitamin D levels during the first six months after colorectal cancer diagnosis. J Steroid Biochem Mol Biol. 2020 May;199:105577. doi: 10.1016/j.jsbmb.2020.105577. Epub 2020 Jan 7.