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NCT05818462 | RECRUITING | Cancer

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

University of Colorado, Denver

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.

Condition or disease

Cancer

Childhood Cancer

Intervention/treatment

Uroflow testing

Bladder Scan

Dysfunctional Voiding Scoring System Survey

DEXA Scan of pelvis and sacral spine

Urine tests for specific biomarkers

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 60 participants
Official Title : Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer
Actual Study Start Date : 2023-07-11
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

Location Details

NCT05818462

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How to Participate

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Locations

RECRUITING

United States, Colorado

Colorado Research Center

Aurora, Colorado, United States, 80217