Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Sponsor

Johns Hopkins University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01169207

Collaborator

(none)

2,500

Enrollment

Location

317

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This current protocol was established in 1996 with the goal of identifying the genetic and environmental components that contribute to the development of IBD, especially in families.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease

Detailed Description

We initiated this research study in 1996 with the overall goal of identifying IBD susceptibility genes. In the beginning, our major focus was recruitment of multiply affected IBD pedigrees for linkage studies, but we have since expanded our study to include singleton cases and spousal/friend as well as population controls for comparison purposes Our recruitment goal is 2500 subjects.

Blood samples obtained from participants are used to isolate lymphocytes for storage, serum for serological analysis of antibodies and other proteins relevant to IBD and DNA for genotyping or sequencing. Lymphocytes may be transformed with EBV to establish immortalized lymphoblastoid cell lines. These cell lines can be used as a secondary DNA source or to study IBD relevant gene, protein expression and cell function

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Study Start Date :

Jul 1, 1996

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Unaffected Individuals who do not have IBD
Affected Individuals with IBD

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ADULTS:

Patients with IBD and their family members who have or do not have IBD.
People that do not have IBD nor have a family member with IBD needed for comparison purposes.

CHILDREN:

Children age 5 or older with IBD and their family members who have or do not have IBD.
Children that do not have IBD nor have a family member with IBD needed for comparison purposes.

Exclusion Criteria:

The only exclusions are age parameters and health reasons that would preclude their enrollment; such as, for anemic patients. Blood-draws on anemic patients may, in certain medical cases, pose a health risk to them; therefore, we request that if they are anemic that they present a letter from their personal physician giving explicit permission for them to join if at the time it is clinically advisable.