Colorectal Cancer Detected by 1H-NMR Spectroscopy

NCT ID: NCT02364154

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group-Blood sampling

-subjects with a normal colonoscopy

Control group-Blood sampling

Intervention Type: OTHER

Determine the metabolic phenotype of blood plasma by NMR spectroscopy

Blood sampling

Intervention Type: OTHER

determine amount and type of free circulating miRNA in blood plasma

Study group-Blood sampling

\- subjects with colorectal cancer after colonoscopy

Control group-Blood sampling

Intervention Type: OTHER

Determine the metabolic phenotype of blood plasma by NMR spectroscopy

Blood sampling

Intervention Type: OTHER

determine amount and type of free circulating miRNA in blood plasma

Interventions

Control group-Blood sampling

Determine the metabolic phenotype of blood plasma by NMR spectroscopy

Intervention Type: OTHER

Blood sampling

determine amount and type of free circulating miRNA in blood plasma

Intervention Type: OTHER

Other Intervention Names

Metabolic phenotype; free circulating miRNA

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. Michiel Thomeer

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michiel thomeer, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg, Hasselt University

Liesbet Mesotten, prof. dr.

Role: STUDY_CHAIR

Ziekenhuis Oost-Limburg, Hasselt University

Philip Caenepeel, prof. dr.

Role: STUDY_CHAIR

Ziekenhuis Oost-Limburg, Hasselt University

Peter Adriaensens, prof. dr.

Role: STUDY_CHAIR

Hasselt University

Kirsten Stinkens, dr.

Role: STUDY_CHAIR

Hasselt University

Evelyne Louis, PhD student

Role: STUDY_CHAIR

Hasselt University

Robby Louis, student

Role: STUDY_CHAIR

Hasselt University

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 24333717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24138801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24744575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24734154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18007604 (View on PubMed)

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

Reference Type: RESULT

Related Links

https://www.omicsonline.org/open-access/metabolic-phenotyping-of-blood-plasma-by-proton-nuclear-magnetic-resonance-to-discriminate-between-colorectal-cancer-breast-cancer-2153-0769-1000187.pdf

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

Other Identifiers

14/070U

Identifier Type: -

Identifier Source: org_study_id