Impact of Chemotherapy on Bladder Function in Childhood Cancer Survivors
This observational study is looking at how two common chemotherapy drugs, vincristine (VCR) and doxorubicin (DOX), might affect bladder function and urine in children who have survived cancer. Researchers want to see if children exposed to these drugs have more bladder problems. They will use a non-invasive urodynamic test (niUDS) to check urine flow, a urine proteomic screen to look at proteins in the urine, and a survey (Dysfunctional Voiding Symptom Score) to understand bladder symptoms. The study hopes to find differences in these tests and surveys between children with and without bladder issues. This study is currently unclear on its recruitment status and plans to enroll 152 participants.
- Study design
- This is an observational study involving 152 participants. It is not a treatment study, but rather looks at existing conditions.
- What's involved
- You would undergo a non-invasive urodynamic test, provide a urine sample for a proteomic screen, and complete a Dysfunctional Voiding Symptom Score survey. Some measurements will be taken immediately and others at 13 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have measurements taken immediately after the first visit and again at 13 months.
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Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nicholas Cost, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Colorado
Who to contact
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Inclusion
Exclusion
What this trial measures
- Proportion of non-normal niUDS patterns between groupsImmediately after niUDS done at the first visit
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.
- Proportion of Elevated Post-Void Residual (PVR) between groups13 months
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.
- Compare Peak Flow Rates (Qmax) between groups13 momths
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
- Compare Average Flow Rates (Qavg) for age/gender13 months
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.
- Compare Urinary Biomarker Levels between groups13 months
1\. Compare urinary biomarker levels between groups i. ATP, BDNF, NGF ii. Two-group t-test for comparing continuous variables 1. Group 1 vs. 2 2. Sub-analysis 1. Group 1a vs. 2a 2. Group 1b vs. 2b The sample size calculation in 1d can apply to each biomarker. Based on published data in other populations with BD, for NGF, ATP and BDNF, we hypothesize to detect a difference of these urinary biomarkers 2x higher in Group 2 (Elevated DVSS scores) vs. Group 1 (Normal DVSS scores). A mixed effects model will be used to estimate and compare a biomarker expression between the two groups by incorporating the individual measurements on each subject into the model, where gender and group assignment will be the predictor. Interaction term between group and gender will be considered to study the effect modification by gender on a biomarker if possible.