Inflammatory Bowel DiseasesNCT03558048
The Effect of IBD Flares on Serum PSA
An observational study of Inflammatory Bowel Diseases and Prostate Cancer, run by Northwestern University at 1 site in United States.
Trial summary
This study will measure Prostate Specific Antigen (PSA) values in men with Inflammatory Bowel Disease (IBD) before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Read more about this study
- Who is it for?
- Ages 40 to 69 years, men only
- Conditions the study is for
- Inflammatory Bowel Diseases, Prostate Cancer
- What is being tested?
- Blood draw
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Oct 2025
- 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 40 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include men ages 40 to 69 presenting to the Northwestern Memorial Hospital Gastroenterology Clinic with a diagnosis of IBD. Men with a history of prostate cancer or prior prostate procedures (transurethral resection or biopsies) will be excluded.
Who may be able to join
- Men, ages 40-69 years old
- Confirmed diagnosis of IBD presenting to the Northwestern Memorial Hospital Gastroenterology Clinic
Who cannot join
- History of prostate cancer or prior prostate procedures (biopsies or transurethral resection)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Jazmine Stockdale, 312-695-8146
About this study
Official title: The Effect of Inflammatory Bowel Disease Flares on Serum Prostate Specific Antigen
This study will measure Prostate Specific Antigen (PSA) values in men with Inflammatory Bowel Disease (IBD) before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Read the detailed description
Over one million adults in the U.S. are estimated to suffer from Inflammatory Bowel Disease (IBD), accounting for more than 2 million ambulatory and emergency room visits annually. This healthcare utilization may lead to an average increase of $5,000-$8,000 in annual medical expenditure per patient. Reducing unnecessary medical interactions and expenditures in this patient group is paramount and requires individualized disease monitoring and healthcare screening
One screening test that may lead to additional exams and costs is the Prostate Specific Antigen (PSA) test used to screen for prostate cancer. While PSA screening can reduce prostate cancer mortality, false-positive elevations are common, especially in the setting of non-malignant prostate inflammation. This research group recently reported in a large retrospective case-control series that after age 65, men with IBD who underwent prostate cancer screening at Northwestern Memorial Hospital (NMH) had higher serum PSA values than non-IBD controls. In addition, men with IBD had a significantly higher risk of clinically significant prostate cancer even when controlling for differences in PSA and other relevant covariates. However, whether the elevation in PSA is related to inflammation in these men with IBD versus a true reflection of an increased risk of prostate cancer is unclear. Furthermore, the interplay of IBD status and screening PSA values is currently unknown.
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
- Conditions
- Inflammatory Bowel Diseases, Prostate Cancer
- Being tested
- Blood draw
- Keywords
- Prostate Specific Antigen, IBD, PSA
- Medical subject headings
- Inflammatory Bowel Diseases, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Subjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels.
| Study group | Role | What they receive |
|---|---|---|
| Men with Inflammatory Bowel Disease | Men with a confirmed diagnosis of IBD between the ages of 40-69 years old. These subjects will have their prostate specific antigen checked via a blood draw during clinic visits over the course of the study period. Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between IBD and PSA
Measure PSA values in men with IBD before, during, and following a flare
Measured: 12 months
Secondary outcomes (1)
Location of disease
Analyze and correlate PSA increase with location of disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Aug 2019
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558048
- Sponsor's protocol ID
- STU00207583
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans at this time to share individual participant data with other researchers. All patient identifying data will be removed prior to transfer to a statistician. No individual research subject will be identified in any reports from the study which will be statistical in nature.
Publications
Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
PubMed 22926499Ananthakrishnan AN, McGinley EL, Saeian K, Binion DG. Trends in ambulatory and emergency room visits for inflammatory bowel diseases in the United States: 1994-2005. Am J Gastroenterol. 2010 Feb;105(2):363-70. doi: 10.1038/ajg.2009.580. Epub 2009 Oct 6.
PubMed 19809414Kappelman MD, Rifas-Shiman SL, Porter CQ, Ollendorf DA, Sandler RS, Galanko JA, Finkelstein JA. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology. 2008 Dec;135(6):1907-13. doi: 10.1053/j.gastro.2008.09.012. Epub 2008 Sep 17.
PubMed 18854185Oesterling JE, Jacobsen SJ, Chute CG, Guess HA, Girman CJ, Panser LA, Lieber MM. Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges. JAMA. 1993 Aug 18;270(7):860-4.
PubMed 7688054
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inflammatory Bowel Disease Flares on Serum Prostate Specific Antigen
- ClinicalTrials.gov ID
- NCT03558048
- Acronym / sponsor ID
- STU00207583
- Conditions
- Inflammatory Bowel Diseases, Prostate Cancer
- Keywords
- Prostate Specific Antigen, IBD, PSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Jun 2018 (actual)
- 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 study will measure Prostate Specific Antigen (PSA) values in men with Inflammatory Bowel Disease (IBD) before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Detailed description
Over one million adults in the U.S. are estimated to suffer from Inflammatory Bowel Disease (IBD), accounting for more than 2 million ambulatory and emergency room visits annually. This healthcare utilization may lead to an average increase of $5,000-$8,000 in annual medical expenditure per patient. Reducing unnecessary medical interactions and expenditures in this patient group is paramount and requires individualized disease monitoring and healthcare screening
One screening test that may lead to additional exams and costs is the Prostate Specific Antigen (PSA) test used to screen for prostate cancer. While PSA screening can reduce prostate cancer mortality, false-positive elevations are common, especially in the setting of non-malignant prostate inflammation. This research group recently reported in a large retrospective case-control series that after age 65, men with IBD who underwent prostate cancer screening at Northwestern Memorial Hospital (NMH) had higher serum PSA values than non-IBD controls. In addition, men with IBD had a significantly higher risk of clinically significant prostate cancer even when controlling for differences in PSA and other relevant covariates. However, whether the elevation in PSA is related to inflammation in these men with IBD versus a true reflection of an increased risk of prostate cancer is unclear. Furthermore, the interplay of IBD status and screening PSA values is currently unknown.
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with Inflammatory Bowel Disease | – | Diagnostic Test: Blood drawMen with a confirmed diagnosis of IBD between the ages of 40-69 years old. These subjects will have their prostate specific antigen checked via a blood draw during clinic visits over the course of the study period. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include men ages 40 to 69 presenting to the Northwestern Memorial Hospital Gastroenterology Clinic with a diagnosis of IBD. Men with a history of prostate cancer or prior prostate procedures (transurethral resection or biopsies) will be excluded.
Key inclusion criteria (2 listed)
- Men, ages 40-69 years old
- Confirmed diagnosis of IBD presenting to the Northwestern Memorial Hospital Gastroenterology Clinic
Key exclusion criteria (1 listed)
- History of prostate cancer or prior prostate procedures (biopsies or transurethral resection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawSubjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels. | Diagnostic test | Men with Inflammatory Bowel Disease |
Primary outcome
Relationship between IBD and PSA
Time frame: 12 months
Measure PSA values in men with IBD before, during, and following a flare
1 secondary outcome
Location of disease
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 22926499Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
- Background: PubMed 19809414Ananthakrishnan AN, McGinley EL, Saeian K, Binion DG. Trends in ambulatory and emergency room visits for inflammatory bowel diseases in the United States: 1994-2005. Am J Gastroenterol. 2010 Feb;105(2):363-70. doi: 10.1038/ajg.2009.580. Epub 2009 Oct 6.
- Background: PubMed 18854185Kappelman MD, Rifas-Shiman SL, Porter CQ, Ollendorf DA, Sandler RS, Galanko JA, Finkelstein JA. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology. 2008 Dec;135(6):1907-13. doi: 10.1053/j.gastro.2008.09.012. Epub 2008 Sep 17.
- Background: PubMed 7688054Oesterling JE, Jacobsen SJ, Chute CG, Guess HA, Girman CJ, Panser LA, Lieber MM. Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges. JAMA. 1993 Aug 18;270(7):860-4.
- Individual participant dataSharing planned: No. There are no plans at this time to share individual participant data with other researchers. All patient identifying data will be removed prior to transfer to a statistician. No individual research subject will be identified in any reports from the study which will be statistical in nature.
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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.
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 Inflammatory Bowel Diseases and Prostate Cancer, run by Northwestern 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 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilajit Kundu, MD (312-695-8146, shilajit.kundu@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between IBD and PSA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558048, which also lists 4 linked publications.
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 24 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.