Ulcerative ColitisThermoNCT02149043
Thermography in Surveillance of Ulcerative Colitis
An observational study of Ulcerative Colitis, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Thermography and Colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be recruited among active ulcerative colitis patients hospitalized in University Hospital Dubrava. Healthy individuals matching sex and BMI to those of recruited ulcerative colitis patients.
Who may be able to join
- Endoscopic diagnosis of active extensive ulcerative colitis
- Stool Calprotectin > 150 mcg/g
- CRP > 5 mg/L
- Signed informed consent form
Who cannot join
- Inability to preform total colonoscopy
- Marked abdominal comorbidities
- Prior abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis
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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Thermography, Colonoscopy
- Keywords
- Inflammatory bowel disease, Ulcerative Colitis, Thermography, Endoscopy, CRP, Fecal Calprotectin
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyDevice
Thermographic imaging of the patient's abdomen surface
ColonoscopyProcedure or surgery
Endoscopic examination of the colon
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis patients | 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. Receives: Device: Thermography; Procedure: Colonoscopy | |
| Healthy volunteers | 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. Receives: Device: Thermography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonći Božin, University Hospital Dubrava
- Investigators
- Marko Banić, MD, PhD, Study director, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149043
- Sponsor's protocol ID
- THERMO-01
- Acronym
- Thermo
- Status last verified
- Jul 2018
- First submitted
- 20 May 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Banić M, et al. Thermography in patients with inflammatory bowel disease and colorectal cancer: evidence and review of the method. Periodicum biologorum 113(4): 439-444, 2011.
Božin, Tonći, et al.
Banić, Marko, et al.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02149043
- Acronym / sponsor ID
- Thermo / THERMO-01
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory bowel disease, Ulcerative Colitis, Thermography, Endoscopy, CRP, Fecal Calprotectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis patients | – | Device: Thermography, Procedure: Colonoscopy30 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. |
| Healthy volunteers | – | Device: Thermography30 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited among active ulcerative colitis patients hospitalized in University Hospital Dubrava. Healthy individuals matching sex and BMI to those of recruited ulcerative colitis patients.
Key inclusion criteria (4 listed)
- Endoscopic diagnosis of active extensive ulcerative colitis
- Stool Calprotectin > 150 mcg/g
- CRP > 5 mg/L
- Signed informed consent form
Key exclusion criteria (3 listed)
- Inability to preform total colonoscopy
- Marked abdominal comorbidities
- Prior abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermographyThermographic imaging of the patient's abdomen surface | Device | Healthy volunteers, Ulcerative Colitis patients |
| ColonoscopyEndoscopic examination of the colon | Procedure or surgery | Ulcerative Colitis patients |
Primary outcome
Change in abdominal surface temperatures in ulcerative colitis patients at 6 months
Time frame: Six 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.
5 secondary outcomes
Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.
Time frame: Baseline and after 6 months
Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.
Time frame: Baseline and after 6 months
Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.
Time frame: Baseline and after 6 months
Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.
Time frame: Baseline and after 6 months
Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.
Time frame: Baseline and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- BackgroundBanić M, et al. Thermography in patients with inflammatory bowel disease and colorectal cancer: evidence and review of the method. Periodicum biologorum 113(4): 439-444, 2011.
- BackgroundBožin, Tonći, et al.
- BackgroundBanić, Marko, et al.
- University Hospital DubravaLink provided by the sponsor.
- University of ZagrebLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Banić, MD, PhD study director
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal surface temperatures in ulcerative colitis patients at 6 months (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149043, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.