Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

• ClinicalTrials.gov Identifier: NCT02735941
• Recruitment Status: Completed
• First Posted: April 13, 2016
• Last Update Posted: July 30, 2018
• Sponsor: Medical University of Graz
• Information provided by (Responsible Party): Medical University of Graz

Tracking Information

• First Submitted Date: February 1, 2016
• First Posted Date: April 13, 2016
• Last Update Posted Date: July 30, 2018
• Actual Study Start Date: June 13, 2017
• Actual Primary Completion Date: July 27, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2016)

Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 6, 2016)

• Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients. [ Time Frame: within 24 months ]
• Assessment of malignancy of colon cancer by tumor staging [ Time Frame: within 24 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases
• Official Title: Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

blood, serum, biopsies

• Sampling Method: Non-Probability Sample
• Study Population: Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz

Condition

• Ulcerative Colitis
• Crohn's Disease
• Colon Cancer

• Intervention: Not Provided

Study Groups/Cohorts

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2017): 31
• Original Estimated Enrollment (submitted: April 6, 2016): 90
• Actual Study Completion Date: July 27, 2018
• Actual Primary Completion Date: July 27, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT02735941
• Other Study ID Numbers: KLI 521-B31
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Medical University of Graz
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of Graz
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rudolf Schicho, PhD; Medical University of Graz

• PRS Account: Medical University of Graz
• Verification Date: July 2018