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OpenTrials
Completed

NCT Number: NCT02735941

Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Expression of G Protein-coupled Receptors and Ligands in Inflammatory Bowel Diseases and Colon Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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