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The COLON Study: Colorectal Cancer Cohort

The COLON Study: Colorectal Cancer: Longitudinal, Observational Study on Nutritional and Lifestyle Factors That May Influence Colorectal Tumour Recurrence, Survival and Quality of Life

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03191110
Acronym
COLON
Enrollment
2000
Registered
2017-06-19
Start date
2010-08-03
Completion date
2030-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms Malignant

Keywords

COLON, colorectal cancer, nutrition, lifestyle, survival, recurrence, quality of life

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.

Interventions

Sponsors

Dutch Cancer Society
CollaboratorOTHER
Wereld Kanker Onderzoek Fonds
CollaboratorOTHER
Funding: World Cancer Research Fund International
CollaboratorUNKNOWN
Funding: ERA-NET on Translational Cancer Research (TRANSCAN)
CollaboratorUNKNOWN
Wageningen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SurvivalAn average follow-up of at least 5 yearsOverall survival
Cancer recurrenceAn average follow-up of at least 5 yearsCancer recurrence
Quality of life (EORTC QLQ-C30)An average follow-up of at least 5 yearsQuality of life

Secondary

MeasureTime frameDescription
Chemotherapy-induced toxicity (QLQ-CIPN20)12 months after diagnosisChemotherapy-induced peripheral neuropathy
Microbiota composition based on 16S rRNA profilingAt diagnosis and 6, 12 and 35 weeks after resectionStool samples
Co-morbiditiesAn average follow-up of at least 5 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026