Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT03558048

Conditions

Inflammatory Bowel Diseases

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Not accepted

Interventions

Blood draw

Study Details

Brief 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). 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

Study ID

NCT03558048

Start date

Aug 1, 2019

Status verified date

Apr, 2024

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men, ages 40-69 years old
  • Confirmed diagnosis of IBD presenting to the Northwestern Memorial Hospital Gastroenterology Clinic

Exclusion Criteria:

  • History of prostate cancer or prior prostate procedures (biopsies or transurethral resection)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Blood draw

Subjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels.

Primary outcome measure

  • Relationship between IBD and PSA [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Shilajit Kundu, MD

312-695-8146shilajit.kundu@nm.org

Jazmine Stockdale, MS

312-694-2417urology@northwestern.edu

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jazmine Stockdale

312-695-8146

More Information

Sponsor

Northwestern University

Last update posted

Apr 24, 2024

Last verified

Apr, 2024

Keywords

  • Prostate Specific Antigen
  • IBD
  • PSA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-04-24.