Inflammatory Bowel DiseaseNCT01032525
Monroe County Inflammatory Bowel Disease (IBD) Registry
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by University of Rochester.
Trial summary
This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- How many people
- 720 participants
- Where
- No sites listed yet
- Study dates
- Jan 1981to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of monroe County who had been diagnosed with Crohn's Disease or Ulcerative Colitis
Who may be able to join
- Patients with IBD who sign consent from 1995-2001
Who cannot join
- Patients without IBD
About this study
Official title: Epidemiologic Study of Inflammatory Bowel Disease in Monroe County, New York
This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).
- Keywords
- Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease in Monroe County, NY
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
not complete
paper is still in progress
Measured: not complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 1981
- Primary completionMay 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Responsible party
- Principal investigator, Lawrence Saubermann, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032525
- Sponsor's protocol ID
- 15094
- Status last verified
- Oct 2015
- First submitted
- 14 Dec 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Inflammatory Bowel Disease in Monroe County, New York
- ClinicalTrials.gov ID
- NCT01032525
- Acronym / sponsor ID
- 15094
- Keywords
- Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease in Monroe County, NY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Jan 1981
- Primary completion
- May 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of monroe County who had been diagnosed with Crohn's Disease or Ulcerative Colitis
Key inclusion criteria (1 listed)
- Patients with IBD who sign consent from 1995-2001
Key exclusion criteria (1 listed)
- Patients without IBD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
not complete
Time frame: not complete
paper is still in progress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by University of Rochester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
not complete (time frame: not complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.