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Colorectal Neoplasms MalignantCOLONNCT03191110

The COLON Study: Colorectal Cancer Cohort

An observational study of Colorectal Neoplasms Malignant, run by Wageningen University at 11 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
Colorectal Neoplasms Malignant
How many people
2,000 participants
Where
11 sitesNetherlands
Study dates
3 Aug 2010to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Netherlands11 sites

  • Ziekenhuisgroep Twente

    Almelo

  • Gelre Hospital

    Apeldoorn

  • Rijnstate Hospital

    Arnhem

  • Slingeland Hospital

    Doetinchem

  • Hospital Gelderse Vallei

    Ede

  • Admiraal De Ruyter Hospital

    Goes/Vlissingen

  • Martini Hospital

    Groningen

  • Canisius Wilhelmina Hospital

    Nijmegen

  • Radboudumc

    Nijmegen

  • Bernhoven Hospital

    Oss

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

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

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.

Being tested
No intervention: observational study
Keywords
COLON, colorectal cancer, nutrition, lifestyle, survival, recurrence, quality of life
Medical subject headings
Colonic Neoplasms, Colorectal Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention: observational studyOther

Study groups in NCT03191110
Study groupRoleWhat they receive
Colorectal cancer patientsNot described
Receives: Other: No intervention: observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Overall survival

    Measured: An average follow-up of at least 5 years

  2. Cancer recurrence

    Cancer recurrence

    Measured: An average follow-up of at least 5 years

  3. Quality of life (EORTC QLQ-C30)

    Quality of life

    Measured: An average follow-up of at least 5 years

Secondary outcomes (3)

  1. Chemotherapy-induced toxicity (QLQ-CIPN20)

    Chemotherapy-induced peripheral neuropathy

    Measured: 12 months after diagnosis

  2. Microbiota composition based on 16S rRNA profiling

    Stool samples

    Measured: At diagnosis and 6, 12 and 35 weeks after resection

  3. Co-morbidities

    Measured: An average follow-up of at least 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start3 Aug 2010
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191110
Sponsor's protocol ID
NL30446.091.09
Other IDs
CMO number 2009/349
Acronym
COLON
Status last verified
Mar 2025
First submitted
9 Jun 2017
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 41076267

  • van Lanen AS, Kok DE, Wesselink E, Derksen JWG, May AM, Smit KC, Koopman M, de Wilt J, Kampman E, van Duijnhoven FJB; COLON and PLCRC studies. Associations between low- and high-fat dairy intake and recurrence risk in people with stage I-III colorectal cancer differ by sex and primary tumour location. Int J Cancer. 2024 Sep 1;155(5):828-838. doi: 10.1002/ijc.34959. Epub 2024 May 3.

    PubMed 38700376

  • 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.

    PubMed 38079324

  • 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.

    PubMed 38070682

  • 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.

    PubMed 37393586

  • 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.

    PubMed 36811565

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms Malignant, run by Wageningen University at 11 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: An average follow-up of at least 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191110, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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