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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT03193515
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Dec 30, 2016
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Amy Oppenheim
[email protected]
310-423-3713
University of California San FranciscoSan FranciscoCalifornia94158-
UT Southwestern Medical Center at DallasDallasTexas75390-

Find similar trials in Los Angeles, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAUT Southwestern Medical Center at Dallas· Dallas, TX

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