CancerNCT05818462
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors
An observational study of Cancer and Childhood Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Cancer, Childhood Cancer
- What is being tested?
- Uroflow testing, Bladder Scan and Dysfunctional Voiding Scoring System Survey
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 2 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cohort 1: Childhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure. Cohort 2: Childhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex.
Who may be able to join
- Patients of any age who were treated were diagnosed in 2007 or later and received chemotherapy for solid tumor malignancy, with completion of therapy (whether chemotherapy or radiation) at least one year prior to study enrollment.
Who cannot join
- Patients with known dysfunctional voiding prior to cancer treatment.
- Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer
The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.
Read the detailed description
The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.
- Conditions
- Cancer, Childhood Cancer
- Being tested
- Uroflow testing, Bladder Scan, Dysfunctional Voiding Scoring System Survey, DEXA Scan of pelvis and sacral spine, Urine tests for specific biomarkers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uroflow testingDiagnostic test
Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Bladder ScanDiagnostic test
Bladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder.
Dysfunctional Voiding Scoring System SurveyOther
The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.
DEXA Scan of pelvis and sacral spineDiagnostic test
DEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine.
Urine tests for specific biomarkersDiagnostic test
Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).
| Study group | Role | What they receive |
|---|---|---|
| Patients who received EBRT to the pelvis. | Childhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure. Receives: Diagnostic Test: Uroflow testing; Diagnostic Test: Bladder Scan; Other: Dysfunctional Voiding Scoring System Survey; Diagnostic Test: DEXA Scan of pelvis and sacral spine; Diagnostic Test: Urine tests for specific biomarkers | |
| Control cohort. | Childhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex. Receives: Diagnostic Test: Uroflow testing; Diagnostic Test: Bladder Scan; Other: Dysfunctional Voiding Scoring System Survey; Diagnostic Test: DEXA Scan of pelvis and sacral spine; Diagnostic Test: Urine tests for specific biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uroflow and Bladder Scan Results
aggregate measured by voiding time (seconds, s), total voided volume (mL), average uroflow rate (mL/s), maximum uroflow rate (mL/s), uroflow pattern or curve (bell-shaped, tower-shaped, staccato, interrupted or plateau), and post void residual (mL)
Measured: 1.5 years
Secondary outcomes (3)
DVSS Scores
- Total DVSS survey scores to determine patient-reported urinary symptom. Gender-specific DVSS total score thresholds: males ≥9, females ≥6. Minimum DVSS score is 0 points. Maximum DVSS score is 30 points.
Measured: 1.5 years
Number of Patients with Osteoporosis
- Rates of osteopenia and osteoporosis, as determined by bone density Z-score using DEXA scan of pelvis and sacral spine. Osteopenia is defined as a z-score between - 1 to -2.5, while osteoporosis is defined as a z-score below -2.5
Measured: 1.5 years
DEXA Scan Results
- Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Jul 2023
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Edwards, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818462
- Sponsor's protocol ID
- 22-1533.cc
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards MH, Nicklawsky A, Beltran G, Stein E, Pyrzanowski J, Rove K, Boone K, Milgrom S, Cost NG. Effect of Pelvic External Beam Radiation Therapy on Lower Urinary Tract Function of Pediatric Patients. Pediatr Blood Cancer. 2025 Nov;72(11):e31996. doi: 10.1002/pbc.31996. Epub 2025 Aug 26.
PubMed 40859673
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT05818462
- Acronym / sponsor ID
- 22-1533.cc
- Conditions
- Cancer, Childhood Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 18 Apr 2023 (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 aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.
Detailed description
The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received EBRT to the pelvis. | – | Diagnostic Test: Uroflow testing, Diagnostic Test: Bladder Scan, Other: Dysfunctional Voiding Scoring System Survey, Diagnostic Test: DEXA Scan of pelvis and sacral spine, Diagnostic Test: Urine tests for specific biomarkersChildhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure. |
| Control cohort. | – | Diagnostic Test: Uroflow testing, Diagnostic Test: Bladder Scan, Other: Dysfunctional Voiding Scoring System Survey, Diagnostic Test: DEXA Scan of pelvis and sacral spine, Diagnostic Test: Urine tests for specific biomarkersChildhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex. |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cohort 1: Childhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure. Cohort 2: Childhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex.
Key inclusion criteria (1 listed)
- Patients of any age who were treated were diagnosed in 2007 or later and received chemotherapy for solid tumor malignancy, with completion of therapy (whether chemotherapy or radiation) at least one year prior to study enrollment.
Key exclusion criteria (2 listed)
- Patients with known dysfunctional voiding prior to cancer treatment.
- Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.
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 |
|---|---|---|
| Uroflow testingUroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes. | Diagnostic test | Control cohort., Patients who received EBRT to the pelvis. |
| Bladder ScanBladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder. | Diagnostic test | Control cohort., Patients who received EBRT to the pelvis. |
| Dysfunctional Voiding Scoring System SurveyThe Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children. | Other | Control cohort., Patients who received EBRT to the pelvis. |
| DEXA Scan of pelvis and sacral spineDEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine. | Diagnostic test | Control cohort., Patients who received EBRT to the pelvis. |
| Urine tests for specific biomarkersUrine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening). | Diagnostic test | Control cohort., Patients who received EBRT to the pelvis. |
Primary outcome
Uroflow and Bladder Scan Results
Time frame: 1.5 years
aggregate measured by voiding time (seconds, s), total voided volume (mL), average uroflow rate (mL/s), maximum uroflow rate (mL/s), uroflow pattern or curve (bell-shaped, tower-shaped, staccato, interrupted or plateau), and post void residual (mL)
3 secondary outcomes
DVSS Scores
Time frame: 1.5 years
Number of Patients with Osteoporosis
Time frame: 1.5 years
DEXA Scan Results
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 40859673Edwards MH, Nicklawsky A, Beltran G, Stein E, Pyrzanowski J, Rove K, Boone K, Milgrom S, Cost NG. Effect of Pelvic External Beam Radiation Therapy on Lower Urinary Tract Function of Pediatric Patients. Pediatr Blood Cancer. 2025 Nov;72(11):e31996. doi: 10.1002/pbc.31996. Epub 2025 Aug 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Edwards, 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 Cancer and Childhood Cancer, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uroflow and Bladder Scan Results (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818462, which also lists 1 linked publication.
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 29 Jan 2026.