Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ulcerative Colitis, Crohn's Disease, Colon Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UC group<br>Patients with ulcerative colitis (active or remission) | |
| CD group<br>Patients with Crohn's disease (active or remission) | |
| Colon cancer group<br>Patients with colon cancer or metastasis | |
| control group<br>healthy individuals | |

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of endoscopic activity scores (Mayo, Harvey Bradshaw index) in IBD patients. |  | within 24 months | 
| Assessment of malignancy of colon cancer by tumor staging |  | within 24 months |