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Verified March 2016 by Medical University of Graz


Information provided by (Responsible Party):

Medical University of Graz

ClinicalTrials.gov Identifier:


First received: February 1, 2016

Last updated: April 6, 2016

Last verified: March 2016

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.

Ulcerative Colitis
Crohn’s Disease
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer

Primary Outcome Measures:

  • Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer [ Time Frame: within 24 months ] [ Designated as safety issue: No ]

    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:

  • Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients. [ Time Frame: within 24 months ] [ Designated as safety issue: No ]
  • Assessment of malignancy of colon cancer by tumor staging [ Time Frame: within 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, serum, biopsies

Estimated Enrollment: 90
Study Start Date: April 2016
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02735941

Medical University of Graz

Principal Investigator: Rudolf Schicho, PhD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02735941     History of Changes
Other Study ID Numbers: KLI 521-B31 
Study First Received: February 1, 2016
Last Updated: April 6, 2016
Health Authority: Austria: Ethikkommission
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:

Colonic Neoplasms
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 13, 2016