NCT03191110

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2010Dec 2030

Study Start

First participant enrolled

August 3, 2010

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

20.3 years

First QC Date

June 9, 2017

Last Update Submit

March 25, 2025

Conditions

Keywords

COLONcolorectal cancernutritionlifestylesurvivalrecurrencequality of life

Outcome Measures

Primary Outcomes (3)

  • Survival

    Overall survival

    An average follow-up of at least 5 years

  • Cancer recurrence

    Cancer recurrence

    An average follow-up of at least 5 years

  • Quality of life (EORTC QLQ-C30)

    Quality of life

    An average follow-up of at least 5 years

Secondary Outcomes (3)

  • Chemotherapy-induced toxicity (QLQ-CIPN20)

    12 months after diagnosis

  • Microbiota composition based on 16S rRNA profiling

    At diagnosis and 6, 12 and 35 weeks after resection

  • Co-morbidities

    An average follow-up of at least 5 years

Study Arms (1)

Colorectal cancer patients

Other: No intervention: observational study

Interventions

Colorectal cancer patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Gelre Hospital

Apeldoorn, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Slingeland Hospital

Doetinchem, Netherlands

Location

Hospital Gelderse Vallei

Ede, Netherlands

Location

Admiraal De Ruyter Hospital

Goes/Vlissingen, Netherlands

Location

Martini Hospital

Groningen, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Bernhoven Hospital

Oss, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Related Publications (12)

  • 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.

    PMID: 24886284BACKGROUND
  • Klaassen-Dekker N, Zoetendal EG, Capuano E, Winkels RM, van Duijnhoven FJ, van Heek NT, Kruyt FM, Ulvik A, McCann A, Ueland PM, de Wilt JH, 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 Dec;122(6):1579-1590. doi: 10.1016/j.ajcnut.2025.10.001. Epub 2025 Oct 10.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for all participants. Stool samples will be collected in a subgroup of colon cancer patients.

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen Kampman, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. ir. Ellen Kampman

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 19, 2017

Study Start

August 3, 2010

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations