Thermography in Surveillance of Ulcerative Colitis

Study Overview
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Brief Summary
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Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

Detailed Description
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Hypothesis: Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis. Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end. Materials and methods: For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations. Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.

Official Title
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Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: Thermography
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopic diagnosis of active extensive ulcerative colitis Stool Calprotectin > 150 mcg/g CRP > 5 mg/L Signed informed consent form Exclusion Criteria: Inability to preform total colonoscopy Marked abdominal comorbidities Prior abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Ulcerative Colitis patients<br>30 patients with active ulcerative colitis will be put throe thermography and colonoscopy. Their stool will be tested for fecal calprotectin and their blood for CRP and other laboratory measures. | Device: Thermography<br>* Thermographic imaging of the patient's abdomen surface<br>Procedure: Colonoscopy<br>* Endoscopic examination of the colon<br>|
| Healthy volunteers<br>30 healthy individuals matching sex and BMI to those of ulcerative colitis patients will be put throe thermography and have their stool tested for fecal calprotectin and their blood for CRP. | Device: Thermography<br>* Thermographic imaging of the patient's abdomen surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal surface temperatures in ulcerative colitis patients at 6 months | Patients will be treated with mesalamin, corticosteroids or biologic therapy according to disease status during 6 months. Abdominal temperatures (maximal, minimum and average temperatures measured in Celsius) recorded by a thermographic camera will be acquired at enrollment and after 6 months of therapy. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers. | Comparison of abdominal surface temperatures (maximum, minimum and average) expressed in Celsius between patients with active ulcerative colitis and healthy controls and also between ulcerative colitis patients in remission and healthy controls. | Baseline and after 6 months | 
| Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis. | Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to the Disease Activity Index (Mayo score). The Index assesses stool frequency (0-3 points, according to severity) rectal bleeding (0-3 points, according to severity), mucosal appearance at endoscopy (0-3 points, according to severity) and physician rating of disease activity (0-3 points, according to severity). All of the points make up a total sum to produce a score ranging from 0 to 12 points (no activity, to most severe activity). All correlations will be performed before and after 6 months of therapy. | Baseline and after 6 months | 
| Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis. | Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to fecal calprotectin (µg/g) levels. All correlations will be performed before and after 6 months of therapy. | Baseline and after 6 months | 
| Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis. | Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to serum C - reactive protein (mg/L) levels. All correlations will be performed before and after 6 months of therapy. | Baseline and after 6 months | 
| Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis. | Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to endoscopic parameters expressed as Mayo endoscopic subscore on a scale 0 - 3. [0 - normal or inactive disease; 1 - mild disease (erythema, decreased vascular pattern, mild friability); 2 - moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 - severe disease (spontaneous bleeding, ulceration)]. All correlations will be performed before and after 6 months of therapy. | Baseline and after 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory bowel disease, Ulcerative Colitis, Thermography, Endoscopy, CRP, Fecal Calprotectin