LymphomaNCT00577538
Prevalence of Lymphoma in IBD
An observational study of Lymphoma and Inflammatory Bowel Disease, run by Indiana University at 1 site in United States.
Trial summary
Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Inflammatory Bowel Disease
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with both Inflammatory bowel disease and lymphoma over the last 30 years.
Who may be able to join
- Inflammatory Bowel disease
- Lymphoma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Prevalence and Risk Factor for Lymphoproliferative Disease in Patients With Inflammatory Bowel Disease
Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to treat IBD (especially immunosuppressives - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed, community based and referral population from the IBD database at Indiana University.
- Conditions
- Lymphoma, Inflammatory Bowel Disease
- Medical subject headings
- Lymphoma, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V. Chiorean, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577538
- Sponsor's protocol ID
- 060358
- Other IDs
- IRB# 0603-58
- Status last verified
- Aug 2015
- First submitted
- 19 Dec 2007
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factor for Lymphoproliferative Disease in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00577538
- Acronym / sponsor ID
- 060358
- Conditions
- Lymphoma, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Dec 2007 (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.
Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to treat IBD (especially immunosuppressives - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed, community based and referral population from the IBD database at Indiana University.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with both Inflammatory bowel disease and lymphoma over the last 30 years.
Key inclusion criteria (2 listed)
- Inflammatory Bowel disease
- Lymphoma
Key exclusion criteria (0 listed)
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 reported in the source record.
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 10 Aug 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.
Michael V. Chiorean, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Inflammatory Bowel Disease, run by Indiana University at 1 site in United States.
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 2 inclusion and 0 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 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 10 Aug 2015.