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Multi Institutional Study in Patient Presenting With Hematuria | Clinical Trials | Clareo Health

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Multi Institutional Study in Patient Presenting With Hematuria

Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria

NCT03122964•MDx Health

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

Detailed Description

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria. The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is willing and able to give written informed consent
•2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months

Exclusion Criteria

•1. Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days)
•2. Subject has a current or past history of genitourinary or urologic cancer within 5 years
•3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years

Locations (1)

UT Southwestern

Dallas, Texas, United States

Key Dates

Start Date

March 31, 2017

Primary Completion Date

February 28, 2020

Completion Date

February 28, 2020

Last Updated

March 6, 2019

Enrollment

1,148

ACTUAL participants

Conditions

Bladder CancerHematuria

Interventions

AssureMDx

DIAGNOSTIC_TEST

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

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Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

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RECRUITINGPHASE2

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

NCT07061964

Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multi Institutional Study in Patient Presenting With Hematuria

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery