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

NCT05818462 | Completed DMC

• 1 other identifier: 22-1533.cc
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  1.5 years

Secondary Outcomes (3)

• DVSS Scores

  1.5 years

• Number of Patients with Osteoporosis

  1.5 years

• DEXA Scan Results

  1.5 years

Other Outcomes (4)

• Biomarker - ATP

  1.5 years

• Biomarker - NGF

  1.5 years

• Biomarker - BNDF

  1.5 years

Study Arms (2)

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.

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.

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

Interventions

Bladder Scan 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.

Control cohort.; Patients who received EBRT to the pelvis.

Uroflow testing 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.

Control cohort.; Patients who received EBRT to the pelvis.

Dysfunctional Voiding Scoring System Survey OTHER

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

Control cohort.; Patients who received EBRT to the pelvis.

DEXA Scan of pelvis and sacral spine 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.

Control cohort.; Patients who received EBRT to the pelvis.

Urine tests for specific biomarkers DIAGNOSTIC_TEST

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

Control cohort.; Patients who received EBRT to the pelvis.

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with known dysfunctional voiding prior to cancer treatment.
• Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Colorado Research Center

Aurora, Colorado, 80217, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Michael Edwards, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 18, 2023
• Study Start: July 11, 2023
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)