Clinical trial NCT05818462: Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors
Official title: Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Childhood Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Uroflow and Bladder Scan Results
timeFrame: 1.5 years
Secondary outcomes:
measure: DVSS Scores
timeFrame: 1.5 years
measure: Number of Patients with Osteoporosis
timeFrame: 1.5 years
measure: DEXA Scan Results
timeFrame: 1.5 years
Other outcomes:
measure: Biomarker - ATP
timeFrame: 1.5 years
measure: Biomarker - NGF
timeFrame: 1.5 years
measure: Biomarker - BNDF
timeFrame: 1.5 years
measure: Biomarker - urine proteomic screening results
timeFrame: 1.5 years
Locations:
city: Aurora
country: United States
facility: Colorado Research Center
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Michael Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References: