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.

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.

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.

Uroflow testing

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.

Bladder Scan

The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.

Dysfunctional Voiding Scoring System Survey

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.

DEXA Scan of pelvis and sacral spine

Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).

Urine tests for specific biomarkers

Michael Edwards, MD

Michael Edwards

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 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.

Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer

Measure biomarker ATP in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

Measure biomarker NGF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

Measure biomarker BNDF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

Measure urinary excreted proteins and peptides via urine proteomic screening in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

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)

2. 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.

4. 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

3. Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors	NCT05818462	Cancer Childhood Cance...	Uroflow testing Bladder Scan Dysfunctional V... DEXA Scan of pe... Urine tests for...	2 Years - 40 Years	University of Colorado, Denver
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors	NCT05818462	Cancer Childhood Cance...	Uroflow testing Bladder Scan Dysfunctional V... DEXA Scan of pe... Urine tests for...	2 Years - 40 Years	University of Colorado, Denver

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