The COLON Study: Colorectal Cancer Cohort

Colorectal Neoplasms Malignant Clinical Trial

— COLON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191110
• Other study ID #: NL30446.091.09
• Secondary ID: CMO number 2009/
• Status: Recruiting
• Start date: August 3, 2010
• Est. completion date: December 2030

Study information

• Verified date: October 2018
• Source: Wageningen University
• Contact: Dieuwertje Kok, PhD
• Phone: +31 317 485 901
• Email: dieuwertje.kok[@]wur.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Neoplasms

Intervention

Other:
• No intervention: observational study

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Gelre Hospital	Apeldoorn
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Slingeland Hospital	Doetinchem
Netherlands	Hospital Gelderse Vallei	Ede
Netherlands	Admiraal De Ruyter Hospital	Goes/Vlissingen
Netherlands	Martini Hospital	Groningen
Netherlands	Canisius Wilhelmina Hospital	Nijmegen
Netherlands	Radboudumc	Nijmegen
Netherlands	Bernhoven Hospital	Oss
Netherlands	Isala Klinieken	Zwolle

Sponsors (5)

Lead Sponsor	Collaborator
Wageningen University	Funding: Alpe D'Huzes / Dutch Cancer Society, Funding: ERA-NET on Translational Cancer Research (TRANSCAN), Funding: Wereld Kanker Onderzoek Fonds, Funding: World Cancer Research Fund International

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

van Zutphen M, Winkels RM, van Duijnhoven FJ, van Harten-Gerritsen SA, Kok DE, van Duijvendijk P, van Halteren HK, Hansson BM, Kruyt FM, Bilgen EJ, de Wilt JH, Dronkers JJ, Kampman E. An increase in physical activity after colorectal cancer surgery is associated with improved recovery of physical functioning: a prospective cohort study. BMC Cancer. 2017 Jan 25;17(1):74. doi: 10.1186/s12885-017-3066-2. — View Citation

Winkels RM, Heine-Bröring 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall survival	An average follow-up of at least 5 years
Primary	Cancer recurrence	Cancer recurrence	An average follow-up of at least 5 years
Primary	Quality of life (EORTC QLQ-C30)	Quality of life	An average follow-up of at least 5 years
Secondary	Chemotherapy-induced toxicity (QLQ-CIPN20)	Chemotherapy-induced peripheral neuropathy	12 months after diagnosis
Secondary	Microbiota composition based on 16S rRNA profiling	Stool samples	At diagnosis and 6, 12 and 35 weeks after resection
Secondary	Co-morbidities		An average follow-up of at least 5 years

External Links

•   Website for studies on Diet and Cancer, Division of Human Nutrition, Wageningen University