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Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

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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

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
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 Type : Observational
Estimated 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 : July 1996
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Unaffected
Individuals who do not have IBD
Affected
Individuals with IBD



Biospecimen Retention:   Samples With DNA
whole blood and derivative from blood, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169207


Contacts
Contact: Kimberly Baytops 410-614-3816 Kbaytop1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: Kimberly Baytops    410-614-3816    Kbaytop1@jhmi.edu   
Principal Investigator: Florin Selaru, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Florin Selaru, M.D. Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01169207     History of Changes
Other Study ID Numbers: NA_00041583
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Johns Hopkins University:
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
IBD
CD
UC
IC

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes