Colorectal Cancer Detected by 1H-NMR Spectroscopy

Study Overview
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Brief Summary
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The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to (i) discriminate between colorectal cancer patients and control subjects and (ii) identify new biomarkers for colorectal cancer. In order to test this hypothesis, the investigators will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects. Multivariate statistics will be performed to assess the discriminative power of the applied methodology in distinguishing between both groups and to identify metabolites with potential as biomarkers for colorectal cancer.

Detailed Description
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Colorectal cancer is one of the most common and deadliest cancers worldwide. Since tumor stage at time of diagnosis is a critical determinant of patient outcome, early detection of colorectal cancer by screening modalities holds the key to improving patient survival. However, current tests, i.e. fecal occult blood testing and colonoscopy, are inadequate for first line screening of colorectal cancer due to limited accuracy and low participation rates, respectively. Therefore, there is an urgent need for new and accurate tests that can be used for en masse screening of colorectal cancer. A blood-based test represents a promising alternative as it takes little time, poses minimal risk to the patient, and is therefore very likely to lead to high participation rates. The development of an effective blood-based screening tool is based on the identification of biomarkers in the blood that are sensitive and specific for colorectal cancer. Studying the metabolic phenotype of colorectal cancer may help to identify such biomarkers since the metabolism of cancer cells is known to differ significantly from that of normal cells. More specifically, the entire metabolism of cancer cells is reprogrammed to increase anabolic reactions that favor cell growth and cell survival. The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to (i) discriminate between colorectal cancer patients and control subjects and (ii) identify new biomarkers for colorectal cancer. In order to test this hypothesis, The investigators will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects. Multivariate statistics will be performed to assess the discriminative power of the applied methodology in distinguishing between both groups and to identify metabolites with potential as biomarkers for colorectal cancer.

Official Title
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Metabolic Phenotyping of Blood Plasma by Means of 1H-NMR Spectroscopy: a New Tool to Detect Colorectal Cancer?

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Control group-Blood sampling
* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has undergone a colonoscopy or is scheduled to undergo a colonoscopy in the future The subject is aged between 40 and 90 years The subject understands the study-specific procedures and provides written informed consent before any study-specific procedures are performed Exclusion Criteria: No fasting starting from 10 p.m. the day prior to blood sampling Medication intake on the morning of blood sampling Diabetes History of cancer during the past 5 years Treatment for cancer during the past 5 years Inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group-Blood sampling<br>-subjects with a normal colonoscopy | Other: Control group-Blood sampling<br>* Determine the metabolic phenotype of blood plasma by NMR spectroscopy<br>* Other names: Metabolic phenotype;Other: Blood sampling<br>* determine amount and type of free circulating miRNA in blood plasma<br>* Other names: free circulating miRNA;|
| Study group-Blood sampling<br>- subjects with colorectal cancer after colonoscopy | Other: Control group-Blood sampling<br>* Determine the metabolic phenotype of blood plasma by NMR spectroscopy<br>* Other names: Metabolic phenotype;Other: Blood sampling<br>* determine amount and type of free circulating miRNA in blood plasma<br>* Other names: free circulating miRNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic phenotype of colorectal cancer | Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor histology | subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum) | day 1 | 
| tumor stage | stage of the colorectal tumor, defined by the TNM classification system (7th edition) | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, screening, coloscopy