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Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

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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

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
Change History Complete list of historical versions of study NCT02735941 on ClinicalTrials.gov Archive Site
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Medical University of Graz
Study Sponsor Medical University of Graz
Collaborators Not Provided
Investigators
Principal Investigator: Rudolf Schicho, PhD Medical University of Graz
PRS Account Medical University of Graz
Verification Date July 2018