The COLON Study: Colorectal Cancer Cohort

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Neoplasms Malignant

Intervention / Treatment
-----------------
* Other: No intervention: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer patients<br> | Other: No intervention: observational study<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COLON, colorectal cancer, nutrition, lifestyle, survival, recurrence, quality of life