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Active, not recruitingNCT03191110COLONUpdated Apr 1, 2025

The COLON Study: Colorectal Cancer Cohort

An observational study in Colorectal Neoplasms Malignant, sponsored by Wageningen University. Active, not recruiting at 11 sites in Netherlands. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Wageningen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Neoplasms Malignant

Keywords

  • COLON
  • colorectal cancer
  • nutrition
  • lifestyle
  • survival
  • recurrence
  • quality of life
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In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Colorectal cancer patients

    Other: No intervention: observational study

Interventions

  • OtherNo intervention: observational study
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What researchers measure

Primary outcomes

  1. Survival

    Overall survival

    Time frame: An average follow-up of at least 5 years

  2. Cancer recurrence

    Cancer recurrence

    Time frame: An average follow-up of at least 5 years

  3. Quality of life (EORTC QLQ-C30)

    Quality of life

    Time frame: An average follow-up of at least 5 years

Secondary outcomes

  1. Chemotherapy-induced toxicity (QLQ-CIPN20)

    Chemotherapy-induced peripheral neuropathy

    Time frame: 12 months after diagnosis

  2. Microbiota composition based on 16S rRNA profiling

    Stool samples

    Time frame: At diagnosis and 6, 12 and 35 weeks after resection

  3. Co-morbidities

    Time frame: An average follow-up of at least 5 years

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Study locations

11 sites
  • 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
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References and documents

Publications

  • 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. PubMed 24886284 ↗
  • 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. PubMed 33544207 ↗
  • 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. PubMed 33531437 ↗
  • 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. PubMed 33478795 ↗
  • 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. PubMed 33067775 ↗
  • 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. PubMed 32190892 ↗
  • 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. PubMed 31917319 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03191110
Lead sponsor
Wageningen University
Collaborators
Dutch Cancer Society, Wereld Kanker Onderzoek Fonds, Funding: World Cancer Research Fund International, Funding: ERA-NET on Translational Cancer Research (TRANSCAN)
Responsible party
Ellen Kampman (prof. dr. ir. Ellen Kampman, Wageningen University) — Principal investigator
First posted
Jun 19, 2017
Start date
Aug 3, 2010
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 1, 2025

Study contacts

Ellen Kampman, PhD
principal investigator · Wageningen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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