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

NCT ID: NCT05818462

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-11

Study Completion Date

2025-05-02

Brief Summary

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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

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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

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Cancer Childhood Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Uroflow testing

Intervention Type DIAGNOSTIC_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 Scan

Intervention Type DIAGNOSTIC_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 Survey

Intervention Type OTHER

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

DEXA Scan of pelvis and sacral spine

Intervention Type DIAGNOSTIC_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 biomarkers

Intervention Type DIAGNOSTIC_TEST

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

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.

Uroflow testing

Intervention Type DIAGNOSTIC_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 Scan

Intervention Type DIAGNOSTIC_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 Survey

Intervention Type OTHER

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

DEXA Scan of pelvis and sacral spine

Intervention Type DIAGNOSTIC_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 biomarkers

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Uroflow 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.

Intervention Type DIAGNOSTIC_TEST

Bladder 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.

Intervention Type DIAGNOSTIC_TEST

Dysfunctional Voiding Scoring System Survey

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

Intervention Type OTHER

DEXA 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.

Intervention Type DIAGNOSTIC_TEST

Urine tests for specific biomarkers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Colorado Research Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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22-1533.cc

Identifier Type: -

Identifier Source: org_study_id

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