NCT01169194

Brief Summary

The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. African Americans with or without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the study, the investigators will ask for information about your health. The investigators will also ask you to give us a blood sample so that they may discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any local facility convenient to you.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Jun 2003Aug 2027

Study Start

First participant enrolled

June 1, 2003

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

24.2 years

First QC Date

June 16, 2010

Last Update Submit

January 15, 2026

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative ColitisIndeterminate ColitisIBDCDUCICAfrican American IBDAfrican American CDAfrican American UCAfrican American ICBlack IBDBlack CDBlack UCBlack ICAfrican American Inflammatory Bowel DiseaseAfrican American Crohn's DiseaseAfrican American Ulcerative ColitisAfrican American Indeterminate ColitisBlack Inflammatory Bowel DiseaseBlack Crohn's DiseaseBlack Ulcerative ColitisBlack Indeterminate Colitis

Outcome Measures

Primary Outcomes (1)

  • IBD Genes

    Single visit, approximately 1 hour

Study Arms (2)

Affected

Patients with IBD

Unaffected

Individuals who do not have IBD

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with Inflammatory Bowel Disease

You may qualify if:

  • African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)
  • African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and derivatives from blood, saliva

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Mark Lazarev, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2010

First Posted

July 26, 2010

Study Start

June 1, 2003

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)