Clinical trial NCT02364154: Colorectal Cancer Detected by 1H-NMR Spectroscopy
Official title: Metabolic Phenotyping of Blood Plasma by Means of 1H-NMR Spectroscopy: a New Tool to Detect Colorectal Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: biomarker
screening
coloscopy
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2015-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colorectal cancer patients and control subjects who undergo a coloscopy without diabetes and/or a history of cancer during the past 5 years, of an age between 40 and 90 years and willing to provide written informed consent.

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.

Eligibility criteria: 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

Primary outcomes:
measure: metabolic phenotype of colorectal cancer
timeFrame: day 1
Secondary outcomes:
measure: tumor histology
timeFrame: day 1
measure: tumor stage
timeFrame: Day 1
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg, Hasselt University
name: Michiel thomeer, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg, Hasselt University
name: Liesbet Mesotten, prof. dr.
role: STUDY_CHAIR
affiliation: Ziekenhuis Oost-Limburg, Hasselt University
name: Philip Caenepeel, prof. dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Peter Adriaensens, prof. dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Kirsten Stinkens, dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Evelyne Louis, PhD student
role: STUDY_CHAIR
affiliation: Hasselt University
name: Robby Louis, student
role: STUDY_CHAIR
References:
citation: Zhang A, Sun H, Yan G, Wang P, Han Y, Wang X. Metabolomics in diagnosis and biomarker discovery of colorectal cancer. Cancer Lett. 2014 Apr 1;345(1):17-20. doi: 10.1016/j.canlet.2013.11.011. Epub 2013 Dec 11.
citation: Wang H, Wang L, Zhang H, Deng P, Chen J, Zhou B, Hu J, Zou J, Lu W, Xiang P, Wu T, Shao X, Li Y, Zhou Z, Zhao YL. (1)H NMR-based metabolic profiling of human rectal cancer tissue. Mol Cancer. 2013 Oct 18;12(1):121. doi: 10.1186/1476-4598-12-121.
citation: Zavoral M, Suchanek S, Majek O, Fric P, Minarikova P, Minarik M, Seifert B, Dusek L. Colorectal cancer screening: 20 years of development and recent progress. World J Gastroenterol. 2014 Apr 14;20(14):3825-34. doi: 10.3748/wjg.v20.i14.3825.
citation: Ganepola GA, Nizin J, Rutledge JR, Chang DH. Use of blood-based biomarkers for early diagnosis and surveillance of colorectal cancer. World J Gastrointest Oncol. 2014 Apr 15;6(4):83-97. doi: 10.4251/wjgo.v6.i4.83.
citation: Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.
citation: Louis R, Louis E, Stinkens K, Mesotten L, de Jonge E, et al. (2016) Metabolic Phenotyping of Blood Plasma by Proton Nuclear Magnetic Resonance to Discriminate between Colorectal Cancer, Breast Cancer and Lung Cancer. Metabolomics (Los Angel) 6: 187. doi: 10.4172/2153-0769.1000187