- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735941
Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases
July 27, 2018 updated by: Medical University of Graz
Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria
- Medical University of Graz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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control group
healthy individuals
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UC group
Patients with ulcerative colitis (active or remission)
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CD group
Patients with Crohn's disease (active or remission)
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Colon cancer group
Patients with colon cancer or metastasis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients.
Time Frame: within 24 months
|
within 24 months
|
Assessment of malignancy of colon cancer by tumor staging
Time Frame: within 24 months
|
within 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rudolf Schicho, PhD, Medical University of Graz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2017
Primary Completion (Actual)
July 27, 2018
Study Completion (Actual)
July 27, 2018
Study Registration Dates
First Submitted
February 1, 2016
First Submitted That Met QC Criteria
April 6, 2016
First Posted (Estimate)
April 13, 2016
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 27, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLI 521-B31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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