Survivors of Childhood CancerNCT04993859
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
An observational study of Survivors of Childhood Cancer and Bladder Dysfunction, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Survivors of Childhood Cancer, Bladder Dysfunction
- What is being tested?
- Non-invasive Urodynamic Test (niUDS), Urinary proteomic screen and Dysfunctional Voiding Symptom Score Survey (DVSS)
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 9 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- Patients with a:
- Primary pelvic tumor
- Pelvic irradiation
- Pre-existing bladder/bowel dysfunction
- Spinal defects
- Neurologic disorder
- Neuro-oncologic tumor or brain metastasis
- Cyclophosphamide or ifosfamide therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Gemma Beltran, (720) 777-4418, gemma.beltran@childrenscolorado.org
Nicholas Cost, MD
About this study
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.
Read the detailed description
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. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.
- Conditions
- Survivors of Childhood Cancer, Bladder Dysfunction
- Being tested
- Non-invasive Urodynamic Test (niUDS), Urinary proteomic screen, Dysfunctional Voiding Symptom Score Survey (DVSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Urodynamic Test (niUDS)Diagnostic test
A noninvasive urodynamics is a simple test used to evaluate urinary flow.
Urinary proteomic screenDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Male Cancer Survivors with DVSS Score ≥ 9 | Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS Receives: Diagnostic Test: Non-invasive Urodynamic Test (niUDS); Diagnostic Test: Urinary proteomic screen; Other: Dysfunctional Voiding Symptom Score Survey (DVSS) | |
| Female Cancer Survivors with DVSS Score ≥ 6 | Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS Receives: Diagnostic Test: Non-invasive Urodynamic Test (niUDS); Diagnostic Test: Urinary proteomic screen; Other: Dysfunctional Voiding Symptom Score Survey (DVSS) | |
| Male Cancer Survivors with DVSS Score < 9 | Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS Receives: Diagnostic Test: Non-invasive Urodynamic Test (niUDS); Diagnostic Test: Urinary proteomic screen; Other: Dysfunctional Voiding Symptom Score Survey (DVSS) | |
| Female Cancer Survivors with DVSS Score < 6 | Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS Receives: Diagnostic Test: Non-invasive Urodynamic Test (niUDS); Diagnostic Test: Urinary proteomic screen; Other: Dysfunctional Voiding Symptom Score Survey (DVSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of non-normal niUDS patterns between groups
- 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.
Measured: Immediately after niUDS done at the first visit
Proportion of Elevated Post-Void Residual (PVR) between groups
- 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.
Measured: 13 months
Compare Peak Flow Rates (Qmax) between groups
- 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
Measured: 13 momths
Compare Average Flow Rates (Qavg) for age/gender
- 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.
Measured: 13 months
Compare Urinary Biomarker Levels between groups
- Compare urinary biomarker levels between groups i. ATP, BDNF, NGF ii. Two-group t-test for comparing continuous variables
- Group 1 vs. 2
- Sub-analysis
- Group 1a vs. 2a
- 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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start2 Jun 2021
- Primary completion9 Jul 2031 (estimated)
- Study completion9 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Nicholas Cost, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993859
- Sponsor's protocol ID
- 20-0680.cc
- Other IDs
- P30CA046934, 1K23DK125673-01
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient Data will be shared after written request to study PI and after approval by local IRB and study committee
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
- ClinicalTrials.gov ID
- NCT04993859
- Acronym / sponsor ID
- 20-0680.cc
- Conditions
- Survivors of Childhood Cancer, Bladder Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Colorado
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 9 Jul 2031 (estimated)
- Study completion
- 9 Jul 2031 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male Cancer Survivors with DVSS Score ≥ 9 | – | Diagnostic Test: Non-invasive Urodynamic Test (niUDS), Diagnostic Test: Urinary proteomic screen, Other: Dysfunctional Voiding Symptom Score Survey (DVSS)Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS |
| Female Cancer Survivors with DVSS Score ≥ 6 | – | Diagnostic Test: Non-invasive Urodynamic Test (niUDS), Diagnostic Test: Urinary proteomic screen, Other: Dysfunctional Voiding Symptom Score Survey (DVSS)Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS |
| Male Cancer Survivors with DVSS Score < 9 | – | Diagnostic Test: Non-invasive Urodynamic Test (niUDS), Diagnostic Test: Urinary proteomic screen, Other: Dysfunctional Voiding Symptom Score Survey (DVSS)Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS |
| Female Cancer Survivors with DVSS Score < 6 | – | Diagnostic Test: Non-invasive Urodynamic Test (niUDS), Diagnostic Test: Urinary proteomic screen, Other: Dysfunctional Voiding Symptom Score Survey (DVSS)Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with a:
- Primary pelvic tumor
- Pelvic irradiation
- Pre-existing bladder/bowel dysfunction
- Spinal defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Urodynamic Test (niUDS)A noninvasive urodynamics is a simple test used to evaluate urinary flow. | Diagnostic test | Female Cancer Survivors with DVSS Score < 6, Female Cancer Survivors with DVSS Score ≥ 6, Male Cancer Survivors with DVSS Score < 9, Male Cancer Survivors with DVSS Score ≥ 9 |
| Urinary proteomic screenUrine 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. | Diagnostic test | Female Cancer Survivors with DVSS Score < 6, Female Cancer Survivors with DVSS Score ≥ 6, Male Cancer Survivors with DVSS Score < 9, Male Cancer Survivors with DVSS Score ≥ 9 |
| Dysfunctional Voiding Symptom Score Survey (DVSS)The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children. | Other | Female Cancer Survivors with DVSS Score < 6, Female Cancer Survivors with DVSS Score ≥ 6, Male Cancer Survivors with DVSS Score < 9, Male Cancer Survivors with DVSS Score ≥ 9 |
Primary outcome
Proportion of non-normal niUDS patterns between groups
Time frame: Immediately 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 groups
Time frame: 13 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 groups
Time frame: 13 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/gender
Time frame: 13 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 groups
Time frame: 13 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Patient Data will be shared after written request to study PI and after approval by local IRB and study committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Cost, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivors of Childhood Cancer and Bladder Dysfunction, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemma Beltran ((720) 777-4418, gemma.beltran@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of non-normal niUDS patterns between groups (time frame: Immediately after niUDS done at the first visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.