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Colorectal Cancer Detected by 1H-NMR Spectroscopy

Completed
Conditions
Colorectal Cancer
Interventions
Other: Control group-Blood sampling
Other: Blood sampling
Registration Number
NCT02364154
Lead Sponsor
Hasselt University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Control group-Blood samplingControl group-Blood sampling-subjects with a normal colonoscopy
Control group-Blood samplingBlood sampling-subjects with a normal colonoscopy
Study group-Blood samplingControl group-Blood sampling- subjects with colorectal cancer after colonoscopy
Study group-Blood samplingBlood sampling- subjects with colorectal cancer after colonoscopy
Primary Outcome Measures
NameTimeMethod
metabolic phenotype of colorectal cancerday 1

Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects

Secondary Outcome Measures
NameTimeMethod
tumor stageDay 1

stage of the colorectal tumor, defined by the TNM classification system (7th edition)

tumor histologyday 1

subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum)

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg

🇧🇪

Genk, Belgium

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