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The Effect of IBD Flares on Serum PSA

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ClinicalTrials.gov Identifier: NCT03558048
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Shilajit Kundu, Northwestern University

Tracking Information
First Submitted Date June 5, 2018
First Posted Date June 15, 2018
Last Update Posted Date July 5, 2019
Estimated Study Start Date August 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2018)
Relationship between IBD and PSA [ Time Frame: 12 months ]
Measure PSA values in men with IBD before, during, and following a flare
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2018)
Location of disease [ Time Frame: 12 months ]
Analyze and correlate PSA increase with location of disease
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of IBD Flares on Serum PSA
Official Title The Effect of Inflammatory Bowel Disease Flares on Serum Prostate Specific Antigen
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Inflammatory Bowel Diseases
  • Prostate Cancer
Intervention Diagnostic Test: 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.
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Blood draw
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 5, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shilajit Kundu, MD 312-695-8146 shilajit.kundu@nm.org
Contact: Faizan Khawaja, BS 312-694-2417 urology@northwestern.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03558048
Other Study ID Numbers STU00207583
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Shilajit Kundu, Northwestern University
Study Sponsor Northwestern University
Collaborators Not Provided
Investigators Not Provided
PRS Account Northwestern University
Verification Date July 2019