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NCT04993859 · ClinicalTrials.gov registry record

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

A clinical trial of Bladder Dysfunction and Survivors of Childhood Cancer, sponsored by University of Colorado, Denver.

Recruiting
Registry status
152
Enrollment target
1
Study location

NCT04993859: Recruiting study of Bladder Dysfunction and Survivors of Childhood Cancer, sponsored by University of Colorado, Denver.

NCT04993859 is a study of Bladder Dysfunction and Survivors of Childhood Cancer that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 152 participants, below the 521-participant average among 4 other Bladder Dysfunction trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04993859, a study of Bladder Dysfunction and Survivors of Childhood Cancer, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
152 participants
Enrollment target
1
Study location

Study Summary

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

Primary Outcome

a. Patterns will be scored by blinded reviewers b. Will calculate an Inter-rater Kappa correlation co-efficient i. Utilize consensus review for discrepancies between reviewers and between the patient's 1st/2nd niUDS for the final assignment ii. Will calculate an intra-test reliability (compare correlation between 1st and 2nd patter) c. Chi-square test to compare proportions of non-normal vs. normal pattern type i. Group 1a vs. 2a ii. Group 1b vs. 2b d. Sample Size Calculation: Based on published

Conditions Studied

Bladder Dysfunction Survivors of Childhood Cancer

Interventions

  • DIAGNOSTIC_TEST Non-invasive Urodynamic Test (niUDS)
  • DIAGNOSTIC_TEST Urinary proteomic screen
  • OTHER Dysfunctional Voiding Symptom Score Survey (DVSS)

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2021-06-02
Est. Completion 2026-07-09
University of Colorado, Denver

1,283 total trials

What NCT04993859 shows while recruiting

NCT04993859 is an observational study that tracks outcomes without assigning an intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 521-participant average among 4 other Bladder Dysfunction trials with a reported enrollment target (71% lower).

The record links to 2 conditions, with Bladder Dysfunction appearing as the primary indexed condition, and to 3 interventions - of which Non-invasive Urodynamic Test (niUDS) is the first listed.

NCT04993859 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT04993859 about?

NCT04993859 is a clinical study titled "Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children". The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

What is the current status of trial NCT04993859?

This trial is currently recruiting. The enrollment target is 152 participants. The study started on 2021-06-02. Estimated completion is 2026-07-09.

What conditions does trial NCT04993859 study?

This clinical trial studies the following conditions: Bladder Dysfunction, Survivors of Childhood Cancer.

What interventions are being tested in trial NCT04993859?

The interventions under investigation include: Non-invasive Urodynamic Test (niUDS) (DIAGNOSTIC_TEST), Urinary proteomic screen (DIAGNOSTIC_TEST), Dysfunctional Voiding Symptom Score Survey (DVSS) (OTHER).

Who is sponsoring clinical trial NCT04993859?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04993859 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT04993859

Source: ClinicalTrials.gov NCT04993859, the US trial registry maintained by the National Library of Medicine. NCT04993859 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.