Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

NCT ID: NCT02735941

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2018-07-27

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.

Conditions

Ulcerative Colitis; Crohn's Disease; Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

UC group

Patients with ulcerative colitis (active or remission)

No interventions assigned to this group

CD group

Patients with Crohn's disease (active or remission)

No interventions assigned to this group

Colon cancer group

Patients with colon cancer or metastasis

No interventions assigned to this group

control group

healthy individuals

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf Schicho, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

KLI 521-B31

Identifier Type: -

Identifier Source: org_study_id