The COLON Study: Colorectal Cancer Cohort (COLON)

October 7, 2018 updated by: Wageningen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
      • Apeldoorn, Netherlands
        • Recruiting
        • Gelre Hospital
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Hospital
      • Doetinchem, Netherlands
        • Recruiting
        • Slingeland Hospital
      • Ede, Netherlands
        • Recruiting
        • Hospital Gelderse Vallei
      • Goes/Vlissingen, Netherlands
        • Recruiting
        • Admiraal de Ruyter Hospital
      • Groningen, Netherlands
        • Recruiting
        • Martini Hospital
      • Nijmegen, Netherlands
        • Recruiting
        • Radboudumc
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Hospital
      • Oss, Netherlands
        • Recruiting
        • Bernhoven Hospital
      • Zwolle, Netherlands
        • Recruiting
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal cancer patients
Other: No intervention: observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: An average follow-up of at least 5 years
Overall survival
An average follow-up of at least 5 years
Cancer recurrence
Time Frame: An average follow-up of at least 5 years
Cancer recurrence
An average follow-up of at least 5 years
Quality of life (EORTC QLQ-C30)
Time Frame: An average follow-up of at least 5 years
Quality of life
An average follow-up of at least 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy-induced toxicity (QLQ-CIPN20)
Time Frame: 12 months after diagnosis
Chemotherapy-induced peripheral neuropathy
12 months after diagnosis
Microbiota composition based on 16S rRNA profiling
Time Frame: At diagnosis and 6, 12 and 35 weeks after resection
Stool samples
At diagnosis and 6, 12 and 35 weeks after resection
Co-morbidities
Time Frame: An average follow-up of at least 5 years
An average follow-up of at least 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2010

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL30446.091.09
  • CMO number 2009/349 (Other Identifier: Medical Ethical Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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