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Trial Title:
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors
NCT ID:
NCT05818462
Condition:
Cancer
Childhood Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Uroflow testing
Description:
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.
Arm group label:
Control cohort.
Arm group label:
Patients who received EBRT to the pelvis.
Intervention type:
Diagnostic Test
Intervention name:
Bladder Scan
Description:
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.
Arm group label:
Control cohort.
Arm group label:
Patients who received EBRT to the pelvis.
Intervention type:
Other
Intervention name:
Dysfunctional Voiding Scoring System Survey
Description:
The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical,
grading of voiding behaviors of children.
Arm group label:
Control cohort.
Arm group label:
Patients who received EBRT to the pelvis.
Intervention type:
Diagnostic Test
Intervention name:
DEXA Scan of pelvis and sacral spine
Description:
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.
Arm group label:
Control cohort.
Arm group label:
Patients who received EBRT to the pelvis.
Intervention type:
Diagnostic Test
Intervention name:
Urine tests for specific biomarkers
Description:
Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).
Arm group label:
Control cohort.
Arm group label:
Patients who received EBRT to the pelvis.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
2 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Colorado Research Center
Address:
City:
Aurora
Zip:
80217
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Edwards
Email:
michael.edwards@childrenscolorado.org
Start date:
July 11, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05818462
