Clinical trial NCT02735941: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Colon Cancer
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing colon cancer screening program at the IBD outpatients clinic of the Medical University of Graz

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.

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

Primary outcomes:
measure: Analysis of cannabinoid receptors in blood leukocytes and biopsies from patients with IBD and colon cancer
timeFrame: within 24 months
Secondary outcomes:
measure: Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients.
timeFrame: within 24 months
measure: Assessment of malignancy of colon cancer by tumor staging
timeFrame: within 24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Rudolf Schicho, PhD
role: PRINCIPAL_INVESTIGATOR
References: