NCT00409396

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

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

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 9, 2015

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

December 5, 2006

Last Update Submit

June 5, 2015

Conditions

Ulcerative Colitis

Keywords

UlcerativeColitisPGE-Mfecal calprotectindisease biomarkers

Outcome Measures

Primary Outcomes (1)

  • Urine for PGEm Levels

    Day of colonoscopy procedure

Secondary Outcomes (4)

  • Blood for CRP

    Day 1

  • Stool for fecal calprotectin

    At least 2 days before colonoscopy procedure (prior to bowel prep)

  • MAYO disease activity score

    Day of colonoscopy procedure

  • Routine colonoscopy for assessment of disease activity

    1-3 weeks after consent

Study Arms (1)

1

EXPERIMENTAL

Fecal calprotectin and urinary PGEm levels will be tested on all participants.

Procedure: Urinary PGEm levelProcedure: fecal calprotectin

Interventions

Urinary PGEm levelPROCEDURE

Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.

1
fecal calprotectinPROCEDURE

Level of fecal calprotectin in comparison to urinary PGEm 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 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

You may not qualify if:

  • Unable to give consent
  • Crohn's disease
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Colitis, UlcerativeUlcerColitis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David A. Schwartz, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 8, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

June 9, 2015

Record last verified: 2014-11

Locations

US(1)