Colorectal Cancer Detected by 1H-NMR Spectroscopy

Colorectal Cancer Clinical Trial

— BIOCOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364154
• Other study ID #: 14/070U
• Status: Completed
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Control group-Blood sampling
Determine the metabolic phenotype of blood plasma by NMR spectroscopy
• Blood sampling
determine amount and type of free circulating miRNA in blood plasma

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View 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. Review. — View 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:

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. ¹H NMR-based metabolic profiling of human rectal cancer tissue. Mol Cancer. 2013 Oct 18;12(1):121. doi: 10.1186/1476-4598-12-121. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic phenotype of colorectal cancer	Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects	day 1
Secondary	tumor histology	subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum)	day 1
Secondary	tumor stage	stage of the colorectal tumor, defined by the TNM classification system (7th edition)	Day 1

External Links

•   Metabolic Phenotyping of Blood Plasma by Proton Nuclear Magnetic Resonance to Discriminate between Colorectal Cancer, Breast Cancer and Lung Cancer