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

Conditions

• Bladder Dysfunction
• Survivors of Childhood Cancer

Eligibility Criteria

Sex

ALL

Age

5 Years - 13 Years

Healthy Volunteers

Not accepted

Interventions

• Non-invasive Urodynamic Test (niUDS) — DIAGNOSTIC_TEST
  A noninvasive urodynamics is a simple test used to evaluate urinary flow.
• Urinary proteomic screen — DIAGNOSTIC_TEST
  Urine proteomics is a powerful platform to identify urinary excreted proteins and peptides in different stages of disease or therapy and to determine their quantity, functions, and interaction.
• Dysfunctional Voiding Symptom Score Survey (DVSS) — OTHER
  The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Study Details

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.

Key Dates

Start date

Jun 2, 2021

Status verified

Oct 2025

Primary completion

Jul 9, 2026

Completion

Jul 9, 2026

Study Design

Enrollment

152 participants (estimated)

Arms

• Arm: Male Cancer Survivors with DVSS Score ≥ 9
  Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS
• Arm: Female Cancer Survivors with DVSS Score ≥ 6
  Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS
• Arm: Male Cancer Survivors with DVSS Score < 9
  Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS
• Arm: Female Cancer Survivors with DVSS Score < 6
  Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS

Primary Outcome Measure

Proportion of non-normal niUDS patterns between groups [ Time Frame: Immediately after niUDS done at the first visit ]

Central Contacts

• Gemma Beltran
  (720) 777-4418
  [email protected]

Locations (1)

Find similar trials in Aurora, CO

Related Studies

• Concomitant Renal and Urinary Bladder Allograft Transplantation
  EARLY_PHASE1 · Recruiting · Mayo Clinic · Rochester, Minnesota
• Vascularized Composite Bladder Allograft Transplantation
  Recruiting · University of Southern California · Los Angeles, California
• Noninvasive Ultrasound Assessment of Detrusor Dysfunction
  Recruiting · Mayo Clinic · Rochester, Minnesota
• Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics
  Recruiting · University of California, San Francisco · San Francisco, California