RecruitingNCT03193515

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Sponsor

Cedars-Sinai Medical Center

Enrollment

300 participants

Start Date

Dec 30, 2016

Study Type

OBSERVATIONAL

Conditions

Bladder Cancer

Summary

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new urine-based blood test panel (called a multiplex ELISA assay) to see if it can reliably detect when bladder cancer has come back in patients who are already being monitored after a previous bladder cancer diagnosis, potentially reducing the need for invasive camera examinations (cystoscopies). **You may be eligible if...** - You are 18 years or older - You have a history of bladder cancer (non-muscle-invasive or muscle-invasive treated with bladder-sparing techniques) diagnosed within the past 24 months - You are currently on a surveillance schedule with regular check-up appointments - You are willing to follow the study's monitoring schedule **You may NOT be eligible if...** - You have an active urinary tract infection - You have other serious urological conditions that could interfere with test results - You are unwilling or unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Kyoto University Graduate School of Medicine

Kyoto, Japan

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NCT03193515

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