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Gene Expression in Inflammatory Bowel Disease
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Johns Hopkins University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01171872
First received: July 28, 2010
Last updated: July 6, 2011
Last verified: July 2011
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Purpose
The causes of inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are unknown and diagnosing them is often difficult. This research is being done to find the genes that may increase the risk of inflammatory bowel disease, and to identify specific protein substances that are related to IBD. The investigators are also looking at cell factors that may predict response to treatment for IBD. In IBD, cells of the gastrointestinal tract (your gut) do not seem to respond to certain substances in a normal way. Scientist have discovered that the immune system, made up of cells and chemicals that defend your body from infections, is working in a way that damages the walls of the gut. You are being asked to join in this study because you are going to have an surgical procedure performed related to your diagnosis of Crohn's disease or ulcerative colitis or for other medical reasons (for comparison purposes). If you join this study, the investigators will study the cells in the resected tissue from your gut to find out why some cells do not act in the normal way in people with IBD as compared to people without IBD. The more the investigators understand about how differently these cells are working, the better doctors and scientists will be able to someday help people with IBD.
| Condition |
|---|
| Inflammatory Bowel Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Gene Expression in Inflammatory Bowel Disease |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Biospecimen Retention: Samples With DNA
Show Detailed Description
whole blood, serum, tissue
| Estimated Enrollment: | 600 |
| Study Start Date: | November 1999 |
| Groups/Cohorts |
|---|
|
Unaffected
Individuals who do not have IBD
|
|
Affected
Individuals who have IBD
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians.
Patient's are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals contact us by phone, mail or email after hearing about our study.
Criteria
Inclusion Criteria:
- All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection with an emphasis on targeting patients diagnosed with C.difficile as a specific control group for comparison.
Exclusion Criteria:
- Persons with bleeding tendencies
- Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171872
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171872
Contacts
| Contact: Patricia Ushry | 1(888) 279-4194 | ibd@jhu.edu | |
| Contact: Denise Spears, B.A. | (410) 502-5846 | dspears1@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University School of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Patricia Ushry 888-279-4194 ibd@jhu.edu | |
| Contact: Denise Spears, BA (410) 502-5846 dspears@jhu.edu | |
| Principal Investigator: Steven R Brant, M.D. | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Steven R Brant, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Steven R. Brant, M.D., Johns Hopkins University-School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01171872 History of Changes |
| Other Study ID Numbers: |
99-09-09-07 |
| Study First Received: | July 28, 2010 |
| Last Updated: | July 6, 2011 |
Keywords provided by Johns Hopkins University:
|
Inflammatory Bowel Disease Inflammatory Bowel Disease (IBD) Crohn's Disease Ulcerative Colitis Indeterminate Colitis |
IBD CD UC IC |
Additional relevant MeSH terms:
|
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
ClinicalTrials.gov processed this record on June 27, 2017