Cancer, Childhood Cancer
Conditions
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTUroflow testing
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.
DIAGNOSTIC_TESTBladder Scan
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.
OTHERDysfunctional Voiding Scoring System Survey
The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.
DIAGNOSTIC_TESTDEXA Scan of pelvis and sacral spine
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.
DIAGNOSTIC_TESTUrine tests for specific biomarkers
Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with known dysfunctional voiding prior to cancer treatment. * Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uroflow and Bladder Scan Results | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DVSS Scores | 1.5 years | 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. |
| Number of Patients with Osteoporosis | 1.5 years | 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 |
| DEXA Scan Results | 1.5 years | 3\. Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Edwards, MD
Children's Hospital Colorado
Outcome results
None listed