The COLON Study: Colorectal Cancer Cohort

NCT ID: NCT03191110

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-03

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Malignant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal cancer patients

No intervention: observational study

Intervention Type OTHER

Interventions

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No intervention: observational study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

Wereld Kanker Onderzoek Fonds

OTHER

Sponsor Role collaborator

Funding: World Cancer Research Fund International

UNKNOWN

Sponsor Role collaborator

Funding: ERA-NET on Translational Cancer Research (TRANSCAN)

UNKNOWN

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Ellen Kampman

prof. dr. ir. Ellen Kampman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Kampman, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status

Gelre Hospital

Apeldoorn, , Netherlands

Site Status

Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Slingeland Hospital

Doetinchem, , Netherlands

Site Status

Hospital Gelderse Vallei

Ede, , Netherlands

Site Status

Admiraal De Ruyter Hospital

Goes/Vlissingen, , Netherlands

Site Status

Martini Hospital

Groningen, , Netherlands

Site Status

Canisius Wilhelmina Hospital

Nijmegen, , Netherlands

Site Status

Radboudumc

Nijmegen, , Netherlands

Site Status

Bernhoven Hospital

Oss, , Netherlands

Site Status

Isala Klinieken

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 24886284 (View on PubMed)

Klaassen-Dekker N, Zoetendal EG, Capuano E, Winkels RM, van Duijnhoven FJB, Tjarda van Heek N, Kruyt FM, Ulvik A, McCann A, Ueland PM, de Wilt JHW, Kampman E, Kok DE. Preoperative plasma short- and branched-chain fatty acids in relation to risk of complications after colorectal cancer surgery: a prospective cohort study. Am J Clin Nutr. 2025 Oct 9:S0002-9165(25)00605-7. doi: 10.1016/j.ajcnut.2025.10.001. Online ahead of print.

Reference Type DERIVED
PMID: 41076267 (View on PubMed)

Smit KC, Derksen JWG, Stellato RK, VAN Lanen AS, Wesselink E, Belt EJT, Balen MC, Coene PPLO, Dekker JWT, DE Groot JW, Haringhuizen AW, VAN Halteren HK, VAN Heek TT, Helgason HH, Hendriks MP, DE Hingh IHJT, Hoekstra R, Houtsma D, Janssen JJB, Kok N, Konsten JLM, Los M, Meijerink MR, Mekenkamp LJM, Peeters KCMJ, Polee MB, Rietbroek RC, Schiphorst AHW, Schrauwen RWM, Schreinemakers J, Sie MPS, Simkens L, Sonneveld EJA, Terheggen F, Iersel LV, Vles WJ, Wasowicz-Kemps DK, DE Wilt JHW, Kok DE, Winkels RM, Kampman E, VAN Duijnhoven FJB, Koopman M, May AM. Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to 5 Years after Diagnosis. Med Sci Sports Exerc. 2024 Apr 1;56(4):623-634. doi: 10.1249/MSS.0000000000003351. Epub 2023 Nov 27.

Reference Type DERIVED
PMID: 38079324 (View on PubMed)

Kok DE, van Duijnhoven FJ, Lubberman FJ, McKay JA, Lanen AV, Winkels RM, Wesselink E, van Halteren HK, de Wilt JH, Ulrich CM, Ulvik A, Ueland PM, Kampman E. Intake and biomarkers of folate and folic acid as determinants of chemotherapy-induced toxicities in patients with colorectal cancer: a cohort study. Am J Clin Nutr. 2024 Feb;119(2):294-301. doi: 10.1016/j.ajcnut.2023.11.023. Epub 2023 Dec 7.

Reference Type DERIVED
PMID: 38070682 (View on PubMed)

van Lanen AS, Kok DE, Wesselink E, Winkels RM, van Halteren HK, de Wilt JHW, Kampman E, van Duijnhoven FJB. Pre- and post-diagnostic dairy intake in relation to recurrence and all-cause mortality in people with stage I-III colorectal cancer. Eur J Nutr. 2023 Oct;62(7):2891-2904. doi: 10.1007/s00394-023-03201-0. Epub 2023 Jul 2.

Reference Type DERIVED
PMID: 37393586 (View on PubMed)

Wesselink E, Valk AW, Kok DE, Lanen AV, de Wilt JH, van Kouwenhoven EA, Schrauwen RW, van Halteren HK, Winkels RM, Balvers MG, Kampman E, van Duijnhoven FJ. Postdiagnostic intake of a more proinflammatory diet is associated with a higher risk of recurrence and all-cause mortality in colorectal cancer survivors. Am J Clin Nutr. 2023 Feb;117(2):243-251. doi: 10.1016/j.ajcnut.2022.11.018. Epub 2022 Dec 22.

Reference Type DERIVED
PMID: 36811565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33544207 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33531437 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33478795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33067775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32190892 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31917319 (View on PubMed)

Related Links

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http://www.colon-studie.nl/colonstudy_eng

Website for studies on Diet and Cancer, Division of Human Nutrition, Wageningen University

Other Identifiers

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CMO number 2009/349

Identifier Type: OTHER

Identifier Source: secondary_id

NL30446.091.09

Identifier Type: -

Identifier Source: org_study_id

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