NCT00086554

Brief Summary

This study will collect tissue specimens to be used for research on inflammatory bowel disease. The tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. Tissue from patients with IBD will be compared with that from patients who do not have the disease Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel disorder may be eligible for this study. Patients with IBD must be at least 4 years of age; those with another disorder must be 18 years of age or older. Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. In addition, patients with IBD provide a blood sample for genetic testing. Several genetic variations, or mutations, may increase the risk of developing IBD; blood samples from patients may help identify these variations.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2004

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2010

Completed
Last Updated

July 2, 2017

Status Verified

January 8, 2010

First QC Date

July 2, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

SurgeryIntestinal ResectionBlood Sample

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings.
  • Ability to give consent or have legally authorized person give consent and agree to sample storage.

You may not qualify if:

  • \. Less than 4 years old.
  • Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses.
  • Ability to give consent and agree to sample storage.
  • \. Less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 2, 2004

First Posted

July 5, 2004

Study Start

July 1, 2004

Study Completion

January 8, 2010

Last Updated

July 2, 2017

Record last verified: 2010-01-08

Locations