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临床试验/NCT03558048
NCT03558048招募中不适用

The Effect of Inflammatory Bowel Disease Flares on Serum Prostate Specific Antigen

Northwestern University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Relationship between IBD and PSA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Relationship between IBD and PSA

时间窗: 12 months

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

次要结局

  • Location of disease(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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