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Active, Not Recruiting

NCT Number: NCT03191110

The COLON Study: Colorectal Cancer Cohort

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Neoplasms Malignant Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Recurrence

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuisgroep Twente, Almelo, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention: observational study

Other

Primary outcomes

  1. Survival

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

    Overall survival

  2. Cancer recurrence

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

    Cancer recurrence

  3. Quality of life (EORTC QLQ-C30)

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

    Quality of life

Secondary outcomes

  1. Chemotherapy-induced toxicity (QLQ-CIPN20)

    Time frame: 12 months after diagnosis

    Chemotherapy-induced peripheral neuropathy

  2. Microbiota composition based on 16S rRNA profiling

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

    Stool samples

  3. Co-morbidities

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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Dutch Cancer Society
  • Funding: ERA-NET on Translational Cancer Research (TRANSCAN)
  • Wereld Kanker Onderzoek Fonds
  • World Cancer Research Fund International

Registry information

Official study 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

Acronym: COLON

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Jun 19, 2017
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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