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Completed

NCT Number: NCT02364154

Colorectal Cancer Detected by 1H-NMR Spectroscopy

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control group-Blood sampling

Other

Determine the metabolic phenotype of blood plasma by NMR spectroscopy

Other names: Metabolic phenotype

Blood sampling

Other

determine amount and type of free circulating miRNA in blood plasma

Other names: free circulating miRNA

Primary outcomes

  1. metabolic phenotype of colorectal cancer

    Time frame: day 1

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

Secondary outcomes

  1. tumor histology

    Time frame: day 1

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

  2. tumor stage

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: BIOCOR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2015
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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