Colorectal Cancer Detected by 1H-NMR Spectroscopy

NCT02364154 | Completed

• 1 other identifier: 14/070U
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

biomarker; screening; coloscopy

Outcome Measures

Primary Outcomes (1)

• metabolic phenotype of colorectal cancer

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

  day 1

Secondary Outcomes (2)

• tumor histology

  day 1

• tumor stage

  Day 1

Study Arms (2)

Control group-Blood sampling

-subjects with a normal colonoscopy

Other: Control group-Blood sampling; Other: Blood sampling

Study group-Blood sampling

\- subjects with colorectal cancer after colonoscopy

Other: Control group-Blood sampling; Other: Blood sampling

Interventions

Control group-Blood sampling OTHER

Determine the metabolic phenotype of blood plasma by NMR spectroscopy

Also known as: Metabolic phenotype

Control group-Blood sampling; Study group-Blood sampling

Blood sampling OTHER

determine amount and type of free circulating miRNA in blood plasma

Also known as: free circulating miRNA

Control group-Blood sampling; Study group-Blood sampling

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (6)

• 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.

  PMID: 24333717 BACKGROUND

• 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.

  PMID: 24138801 BACKGROUND

• 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.

  PMID: 24744575 BACKGROUND

• 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.

  PMID: 24734154 BACKGROUND

• 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.

  PMID: 18007604 BACKGROUND

• 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

  RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

* blood plasma for NMR spectroscopy * blood sample for free circulating miRNA

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michiel thomeer, prof. dr.

  Ziekenhuis Oost-Limburg, Hasselt University

  PRINCIPAL INVESTIGATOR

• Liesbet Mesotten, prof. dr.

  Ziekenhuis Oost-Limburg, Hasselt University

  STUDY CHAIR

• Philip Caenepeel, prof. dr.

  Ziekenhuis Oost-Limburg, Hasselt University

  STUDY CHAIR

• Peter Adriaensens, prof. dr.

  Hasselt University

  STUDY CHAIR

• Kirsten Stinkens, dr.

  Hasselt University

  STUDY CHAIR

• Evelyne Louis, PhD student

  Hasselt University

  STUDY CHAIR

• Robby Louis, student

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

BE (1)