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Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735941
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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.

Condition or disease
Ulcerative Colitis Crohn's Disease Colon 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 Design
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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Biospecimen Retention:   Samples Without DNA
blood, serum, biopsies

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735941


Locations
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Austria
Medical University of Graz
Graz, Austria
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Rudolf Schicho, PhD Medical University of Graz
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02735941    
Other Study ID Numbers: KLI 521-B31
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Colonic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms