NCT00577538

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

December 19, 2007

Last Update Submit

August 7, 2015

Conditions

LymphomaInflammatory Bowel Disease

Study Arms (2)

1

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with both Inflammatory bowel disease and lymphoma over the last 30 years.

You may qualify if:

  • Inflammatory Bowel disease
  • Lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

LymphomaInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Michael V. Chiorean, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 20, 2007

Study Start

April 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

US(1)