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NCT03193515 · ClinicalTrials.gov registry record

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

A clinical trial of Bladder Cancer, sponsored by Cedars-Sinai Medical Center.

Recruiting
Registry status
300
Enrollment target
4
Study locations

NCT03193515: Recruiting study of Bladder Cancer, sponsored by Cedars-Sinai Medical Center.

NCT03193515 is a study of Bladder Cancer that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 300 participants, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03193515, a study of Bladder Cancer, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.

RECRUITING
Registry status
300 participants
Enrollment target
4
Study locations

Study 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.

Primary Outcome

To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.

Conditions Studied

Study Locations (4)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • University of California San Francisco - San Francisco

Texas

  • UT Southwestern Medical Center at Dallas - Dallas

Other

  • Kyoto University Graduate School of Medicine - Kyoto

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2016-12-30
Est. Completion 2028-08
Cedars-Sinai Medical Center

339 total trials

What NCT03193515 shows while recruiting

NCT03193515 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 0 interventions.

NCT03193515 reports a single indexed study location in California, Texas, Other.

Frequently Asked Questions

What is clinical trial NCT03193515 about?

NCT03193515 is a clinical study titled "A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer". 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 t...

What is the current status of trial NCT03193515?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2016-12-30. Estimated completion is 2028-08.

What conditions does trial NCT03193515 study?

This clinical trial studies the following conditions: Bladder Cancer.

Who is sponsoring clinical trial NCT03193515?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03193515 being conducted?

This trial has 4 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Bladder Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03193515's enrollment target sits among peer trials

300 48th of 175 higher than 128 of 175 other Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03193515, the US trial registry maintained by the National Library of Medicine. NCT03193515 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.