NCT00496548

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

8.3 years

First QC Date

July 2, 2007

Last Update Submit

April 30, 2017

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Urine for PGE-M levels

    Day of colonoscopy procedure

Secondary Outcomes (4)

  • Blood for C-reactive protein (CRP) levels

    Day 1

  • Stool for fecal calprotectin

    Prior to colonoscopy procedure (before beginning bowel prep)

  • Routine colonoscopy for assessment of disease activity

    1-3 weeks from consent

  • Harvey-Bradshaw index disease activity score

    Day of colonoscopy procedure

Study Arms (1)

1

EXPERIMENTAL

Fecal calprotectin and urinary PGE-M levels will be tested on all participants.

Procedure: Fecal calprotectinProcedure: Urinary PGE-M Level

Interventions

Fecal calprotectinPROCEDURE

Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.

1
Urinary PGE-M LevelPROCEDURE

Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to give consent
  • Ulcerative colitis
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Clinical Research; Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2285, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • David A. Schwartz, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 4, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)