Ulcerative ColitisNCT00409396
A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
A study testing Urinary PGEm level and fecal calprotectin in people with Ulcerative Colitis, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Urinary PGEm level and fecal calprotectin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient male or female 18 years or older
- Confirmed diagnosis of ulcerative colitis
- Informed consent obtained
- Able to give blood, urine and stool samples
- Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care
Who cannot join
- Unable to give consent
- Crohn's disease
- Does not meet inclusion criteria
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.
Read the detailed description
The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.
Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).
- Conditions
- Ulcerative Colitis
- Being tested
- Urinary PGEm level, fecal calprotectin
- Keywords
- Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers
- Medical subject headings
- Colitis, Ulcerative, Ulcer, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary PGEm levelProcedure or surgery
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
fecal calprotectinProcedure or surgery
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fecal calprotectin and urinary PGEm levels will be tested on all participants. Receives: Procedure: Urinary PGEm level; Procedure: fecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine for PGEm Levels
Measured: Day of colonoscopy procedure
Secondary outcomes (4)
Blood for CRP
Measured: Day 1
Stool for fecal calprotectin
Measured: At least 2 days before colonoscopy procedure (prior to bowel prep)
MAYO disease activity score
Measured: Day of colonoscopy procedure
Routine colonoscopy for assessment of disease activity
Measured: 1-3 weeks after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, David Schwartz, Vanderbilt University
- Investigators
- David A. Schwartz, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409396
- Sponsor's protocol ID
- Urinary PGE-M UC
- Status last verified
- Nov 2014
- First submitted
- 5 Dec 2006
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
- ClinicalTrials.gov ID
- NCT00409396
- Acronym / sponsor ID
- Urinary PGE-M UC
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Dec 2006 (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.
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.
Detailed description
The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.
Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Urinary PGEm level, Procedure: fecal calprotectinFecal calprotectin and urinary PGEm levels will be tested on all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient male or female 18 years or older
- Confirmed diagnosis of ulcerative colitis
- Informed consent obtained
- Able to give blood, urine and stool samples
- Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care
Key exclusion criteria (4 listed)
- Unable to give consent
- Crohn's disease
- Does not meet inclusion criteria
- Pregnant
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 |
|---|---|---|
| Urinary PGEm levelLevel of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis. | Procedure or surgery | 1 |
| fecal calprotectinLevel of fecal calprotectin in comparison to urinary PGEm and serum CRP levels. | Procedure or surgery | 1 |
Primary outcome
Urine for PGEm Levels
Time frame: Day of colonoscopy procedure
4 secondary outcomes
Blood for CRP
Time frame: Day 1
Stool for fecal calprotectin
Time frame: At least 2 days before colonoscopy procedure (prior to bowel prep)
MAYO disease activity score
Time frame: Day of colonoscopy procedure
Routine colonoscopy for assessment of disease activity
Time frame: 1-3 weeks after consent
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 9 Jun 2015.
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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.
David A. Schwartz, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary PGEm level and fecal calprotectin in people with Ulcerative Colitis, run by Vanderbilt University at 1 site in United States.
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 5 inclusion and 4 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 9 Jun 2015. 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 United States. 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?
Urine for PGEm Levels (time frame: Day of colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2015.