Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis; Colon Cancer

• Registration Number: NCT02735941
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-13
• Study Start: 2017-06-13
• Status Verified: 2018-07
• Primary Completion: 2018-07-27
• Study Completion: 2018-07-27
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer	within 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients.	within 24 months
Assessment of malignancy of colon cancer by tumor staging	within 24 months

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria