We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01169207
Recruitment Status : Recruiting
First Posted : July 26, 2010
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

July 23, 2010
July 26, 2010
February 6, 2018
July 1996
December 2020   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01169207 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Johns Hopkins Crohn's Disease and Ulcerative Colitis Study
Johns Hopkins Crohn's Disease and Ulcerative Colitis Study
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.

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

Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
whole blood and derivative from blood, saliva
Non-Probability Sample
IBD patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals may contact us by phone, mail or email after hearing about our study
Inflammatory Bowel Disease
Not Provided
  • Unaffected
    Individuals who do not have IBD
  • Affected
    Individuals with IBD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
December 2020
December 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
Yes
Contact: Kimberly Baytops 410-614-3816 Kbaytop1@jhmi.edu
United States
 
 
NCT01169207
NA_00041583
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Florin Selaru, M.D. Johns Hopkins University
Johns Hopkins University
February 2018