- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02364154
Colorectal Cancer Detected by 1H-NMR Spectroscopy (BIOCOR)
Metabolic Phenotyping of Blood Plasma by Means of 1H-NMR Spectroscopy: a New Tool to Detect Colorectal Cancer?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Control group-Blood sampling
-subjects with a normal colonoscopy
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Determine the metabolic phenotype of blood plasma by NMR spectroscopy
Andre navn:
determine amount and type of free circulating miRNA in blood plasma
Andre navn:
|
Study group-Blood sampling
- subjects with colorectal cancer after colonoscopy
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Determine the metabolic phenotype of blood plasma by NMR spectroscopy
Andre navn:
determine amount and type of free circulating miRNA in blood plasma
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
metabolic phenotype of colorectal cancer
Tidsramme: day 1
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Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects
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day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
tumor histology
Tidsramme: day 1
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subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum)
|
day 1
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tumor stage
Tidsramme: Day 1
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stage of the colorectal tumor, defined by the TNM classification system (7th edition)
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Day 1
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: peter Adriaensens, prof. dr., Hasselt University
- Hovedetterforsker: Michiel thomeer, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Studiestol: Liesbet Mesotten, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Studiestol: Philip Caenepeel, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Studiestol: Kirsten Stinkens, dr., Hasselt University
- Studiestol: Evelyne Louis, PhD student, Hasselt University
- Studiestol: Robby Louis, student, Hasselt University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14/070U
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