Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

Ulcerative Colitis Clinical Trial

Official title:

Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735941
• Other study ID #: KLI 521-B31
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: July 2018
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colon Cancer
• Colonic Neoplasms
• Crohn Disease
• Crohn's Disease
• Gastrointestinal Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer	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.	within 24 months
Secondary	Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients.		within 24 months
Secondary	Assessment of malignancy of colon cancer by tumor staging		within 24 months