Crohn's DiseaseNCT00496548
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
A study testing Fecal calprotectin and Urinary PGE-M Level in people with Crohn's Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Fecal calprotectin and Urinary PGE-M Level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2015
- 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 Crohn's disease
- Informed consent obtained
- Able to give blood, urine and stool samples
- Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care
Who cannot join
- Unable to give consent
- Ulcerative colitis
- Does not meet inclusion criteria
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
GI Clinical Research; Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2285
About this study
Official title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.
Read the detailed description
The available clinical measures of Crohn's disease 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 inflammatory bowel disease (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 Crohn's 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.
- Conditions
- Crohn's Disease
- Being tested
- Fecal calprotectin, Urinary PGE-M Level
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal calprotectinProcedure or surgery
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Urinary PGE-M LevelProcedure or surgery
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fecal calprotectin and urinary PGE-M levels will be tested on all participants. Receives: Procedure: Fecal calprotectin; Procedure: Urinary PGE-M Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine for PGE-M levels
Measured: Day of colonoscopy procedure
Secondary outcomes (4)
Blood for C-reactive protein (CRP) levels
Measured: Day 1
Stool for fecal calprotectin
Measured: Prior to colonoscopy procedure (before beginning bowel prep)
Routine colonoscopy for assessment of disease activity
Measured: 1-3 weeks from consent
Harvey-Bradshaw index disease activity score
Measured: Day of colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, David Schwartz, Vanderbilt University Medical Center
- Investigators
- David A. Schwartz, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496548
- Sponsor's protocol ID
- Urinary PGE-M CD
- Status last verified
- Apr 2017
- First submitted
- 2 Jul 2007
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. 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 Crohn's Disease Activity
- ClinicalTrials.gov ID
- NCT00496548
- Acronym / sponsor ID
- Urinary PGE-M CD
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Aug 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jul 2007 (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 Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.
Detailed description
The available clinical measures of Crohn's disease 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 inflammatory bowel disease (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 Crohn's 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Fecal calprotectin, Procedure: Urinary PGE-M LevelFecal calprotectin and urinary PGE-M 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 Crohn's disease
- Informed consent obtained
- Able to give blood, urine and stool samples
- Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care
Key exclusion criteria (4 listed)
- Unable to give consent
- Ulcerative colitis
- 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 |
|---|---|---|
| Fecal calprotectinFecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels. | Procedure or surgery | 1 |
| Urinary PGE-M LevelUrinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels. | Procedure or surgery | 1 |
Primary outcome
Urine for PGE-M levels
Time frame: Day of colonoscopy procedure
4 secondary outcomes
Blood for C-reactive protein (CRP) levels
Time frame: Day 1
Stool for fecal calprotectin
Time frame: Prior to colonoscopy procedure (before beginning bowel prep)
Routine colonoscopy for assessment of disease activity
Time frame: 1-3 weeks from consent
Harvey-Bradshaw index disease activity score
Time frame: Day of colonoscopy procedure
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 2 May 2017.
- 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.
David A. Schwartz, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal calprotectin and Urinary PGE-M Level in people with Crohn's Disease, run by Vanderbilt University Medical Center 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 2 May 2017. 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 PGE-M 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 2 May 2017.