The Effect of IBD Flares on Serum PSA

NCT03558048 | Recruiting

• 1 other identifier: STU00207583
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate Specific Antigen; IBD; PSA

Outcome Measures

Primary Outcomes (1)

• Relationship between IBD and PSA

  Measure PSA values in men with IBD before, during, and following a flare

  12 months

Secondary Outcomes (1)

• Location of disease

  12 months

Study Arms (1)

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.

Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_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.

Men with Inflammatory Bowel Disease

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 22926499 BACKGROUND

• Ananthakrishnan 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.

  PMID: 19809414 BACKGROUND

• Kappelman 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.

  PMID: 18854185 BACKGROUND

• Oesterling 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.

  PMID: 7688054 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Shilajit Kundu, MD

CONTACT

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

Jazmine Stockdale, MS

CONTACT

312-694-2417; urology@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: August 1, 2019
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)