The COLON Study: Colorectal Cancer Cohort

Sponsor

Wageningen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03191110

Collaborator

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

2,000

Enrollment

Locations

243.9

Anticipated Duration (Months)

181.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Malignant	Other: No intervention: observational study

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 3, 2010

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

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

Arm

Intervention/Treatment

Colorectal cancer patients

Other: No intervention: observational study

Outcome Measures

Primary Outcome Measures

Survival [An average follow-up of at least 5 years]
Overall survival
Cancer recurrence [An average follow-up of at least 5 years]
Cancer recurrence
Quality of life (EORTC QLQ-C30) [An average follow-up of at least 5 years]
Quality of life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Ziekenhuisgroep Twente	Almelo	Netherlands
2	Gelre Hospital	Apeldoorn	Netherlands
3	Rijnstate Hospital	Arnhem	Netherlands
4	Slingeland Hospital	Doetinchem	Netherlands
5	Hospital Gelderse Vallei	Ede	Netherlands
6	Admiraal De Ruyter Hospital	Goes/Vlissingen	Netherlands
7	Martini Hospital	Groningen	Netherlands
8	Canisius Wilhelmina Hospital	Nijmegen	Netherlands
9	Radboudumc	Nijmegen	Netherlands
10	Bernhoven Hospital	Oss	Netherlands
11	Isala Klinieken	Zwolle	Netherlands