- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Genk, Belgique, 3600
- Ziekenhuis Oost-Limburg
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Control group-Blood sampling
-subjects with a normal colonoscopy
|
Determine the metabolic phenotype of blood plasma by NMR spectroscopy
Autres noms:
determine amount and type of free circulating miRNA in blood plasma
Autres noms:
|
|
Study group-Blood sampling
- subjects with colorectal cancer after colonoscopy
|
Determine the metabolic phenotype of blood plasma by NMR spectroscopy
Autres noms:
determine amount and type of free circulating miRNA in blood plasma
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
metabolic phenotype of colorectal cancer
Délai: day 1
|
Significant metabolic changes in blood plasma of colorectal cancer patients compared with control subjects
|
day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
tumor histology
Délai: day 1
|
subtype of histology of the colorectal tumor (according to WHO histological classification of tumors of the colon and rectum)
|
day 1
|
|
tumor stage
Délai: Day 1
|
stage of the colorectal tumor, defined by the TNM classification system (7th edition)
|
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: peter Adriaensens, prof. dr., Hasselt University
- Chercheur principal: Michiel thomeer, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Chaise d'étude: Liesbet Mesotten, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Chaise d'étude: Philip Caenepeel, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University
- Chaise d'étude: Kirsten Stinkens, dr., Hasselt University
- Chaise d'étude: Evelyne Louis, PhD student, Hasselt University
- Chaise d'étude: Robby Louis, student, Hasselt University
Publications et liens utiles
Publications générales
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14/070U
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .