Verified March 2016 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT02735941
First received: February 1, 2016
Last updated: April 6, 2016
Last verified: March 2016
The purpose of the study is to investigate phospholipid ligands and their receptors in inflammatory bowel diseases and colon cancer. Several new species of lipids have been recently discovered which are able to transmit information to cancer cells in the large intestine. The lipids and their responsive receptors build an axis that is thought to influence the development of inflammation and cancer.
| Ulcerative Colitis Crohn’s Disease Colon Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer |
- Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer [ Time Frame: within 24 months ] [ Designated as safety issue: No ]
Protein content of cannabinoid receptors and G protein-coupled receptor 55 are measured by flow cytometry in blood leukocytes of patients with ulcerative colitis or Crohn’s disease, and of healthy individuals. Transcripts of cannabinoid receptors and G protein-coupled receptor 55 are also measured in colonic mucosal biopsies of IBD/colon cancer patients and healthy individuals by polymerase chain reaction.
- Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients. [ Time Frame: within 24 months ] [ Designated as safety issue: No ]
- Assessment of malignancy of colon cancer by tumor staging [ Time Frame: within 24 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
blood, serum, biopsies
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | April 2020 |
| Estimated Primary Completion Date: | April 2020 (Final data collection date for primary outcome measure) |
| UC group
Patients with ulcerative colitis (active or remission) |
| CD group
Patients with Crohn’s disease (active or remission) |
| Colon cancer group
Patients with colon cancer or metastasis |
| control group
healthy individuals |
Expression of cannabinoid receptors are examined in mucosal biopsies of the colon and blood leukocytes of patients with inflammatory bowel disease (IBD) or colon cancer in comparison to healthy individuals by polymerase chain reaction, Western Blots and flow cytometry. Colonic endoscopic biopsies and blood are collected from adult patients with confirmed active Ulcerative colitis (UC) and Crohn’s disease (CD), adult UC and CD patients in remission, colon cancer patients and from healthy individuals (controls). Biopsies from healthy individuals (control group) will have undergone colonoscopy during standard screening for colorectal cancer or for the diagnostic workup of gastrointestinal symptoms without endoscopic or histologic evidence of colonic disease. For UC patients, duration and location of disease (Montreal classification), endoscopic (Mayo score) and clinical activity score, histological features and current and previous treatments (5-aminosalicylic acid, corticosteroids, immunomodulators) will be recorded. For CD patients, duration and location of disease is assessed, a HarveyBradshaw Index and activity will be scored, histological features and current and previous treatments will be recorded. Blood is collected and immediately processed for flow cytometric experiments. Phospholipids are measured in serum and in colonic mucosal biopsy samples of all cohorts by mass spectrometry.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz
Inclusion Criteria:
- Diagnosis of Ulcerative colitis (active/remission)
- or Crohn’s disease (active/remission)
- or Colon cancer (or metastasis)
Exclusion Criteria:
- unable to give informed consent
- pregnancy
- intermittent illness or comorbidity during Crohn/Ulcerative colitis
Please refer to this study by its ClinicalTrials.gov identifier: NCT02735941
Medical University of Graz
| Principal Investigator: | Rudolf Schicho, PhD | Medical University of Graz |
| Responsible Party: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT02735941 History of Changes |
| Other Study ID Numbers: | KLI 521-B31 |
| Study First Received: | February 1, 2016 |
| Last Updated: | April 6, 2016 |
| Health Authority: | Austria: Ethikkommission |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
| Colonic Neoplasms Crohn Disease Colitis Colitis, Ulcerative Inflammatory Bowel Diseases Gastrointestinal Diseases Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Colonic Diseases Intestinal Diseases Gastroenteritis |
ClinicalTrials.gov processed this record on September 13, 2016