Health TrialsbyHealthPanel

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

ConditionsSurvivors of Childhood CancerBladder Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-13
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 5-13 years old

A history of cancer

Treatment with a chemotherapy regimen including VCR and/or DOX

Completion of chemotherapy at least one year prior to study enrollment and survey completion.

Disqualifiers

Primary pelvic tumor

Pelvic irradiation

Pre-existing bladder/bowel dysfunction

Spinal defects

Trial population

Childhood cancer survivors that have been treated with a chemotherapy regimen including VCR and/or DOX, completion of chemotherapy at least one year prior to study enrollment and survey completion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

    The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Treatment groups

152 Participants
are divided into 4 treatment groups
Group A: Male Cancer Survivors with DVSS Score ≥ 93 interventions
Group B: Female Cancer Survivors with DVSS Score ≥ 63 interventions
Group C: Male Cancer Survivors with DVSS Score < 93 interventions
Group D: Female Cancer Survivors with DVSS Score < 63 interventions

Trial outcomes

Primary outcomes

1

Proportion of non-normal niUDS patterns between groups

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 data of niUDS patterns in children with normal bladder function, we expect 15% of those children in Group 2 to have non-normal niUDS patterns. We hypothesize that 40% of children in Group 1 to have non-normal niUDS patterns. 38 subjects in each gender sub-group provide 80% power to detect this 25% difference with an one-sided chi-square test with an alpha of 0.05.

Time frame
Immediately after niUDS done at the first visit
2

Proportion of Elevated Post-Void Residual (PVR) between groups

a. Will use an "average PVR" between the 1st/2nd niUDS for the analysis b. Chi-square test to compare proportions of elevated PVR i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: Based on published data of PVR in children with normal bladder function, we expect 1.5% of those children in Group 2 to have elevated PVR. We hypothesize that 25% of children in Group 1 to have an elevated PVR. 21 subjects in each gender sub-group provide 80% power to detect this 23.5% difference with an one-sided chi-square test with an alpha of 0.05.

Time frame
13 months
3

Compare Peak Flow Rates (Qmax) between groups

a. Will use the average of the two Qmax between the 1st/2nd flow rate for the analysis b. Two group t-test for comparing continuous variables (Qmax) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: 38 subjects in Group 1a and 2a provide 80% power to detect an effect size of 0.7 (mean difference divided by the common standard deviation) using a 2-sided two-group test with an alpha of 0.05. if the outcome is not normally distributed, transformation will be carried out so the distribution will be approximately normal. This power calculation also applies to the comparison between Group 1b vs 2b

Time frame
13 momths
4

Compare Average Flow Rates (Qavg) for age/gender

a. Will use the average of the two Qavg between the 1st/2nd flow rate for the analysis b. Two group ttest for comparing continuous variables (Qavg) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. See the power calculation in 3c.

Time frame
13 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Children's Hospital Colorado

Collaborator

Source ClinicalTrials.gov
Apply now