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NCT04775355 · ClinicalTrials.gov registry record
Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer
A clinical trial of Stage IV Prostate Cancer AJCC v7 and Stage III Prostate Cancer AJCC v7, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT04775355: Recruiting study of Stage IV Prostate Cancer AJCC v7 and Stage III Prostate Cancer AJCC v7, sponsored by City of Hope Medical Center.
NCT04775355 is a study of Stage IV Prostate Cancer AJCC v7 and Stage III Prostate Cancer AJCC v7 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 30 participants, below the 128-participant average among 5 other Stage IV Prostate Cancer AJCC v7 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04775355, a study of Stage IV Prostate Cancer AJCC v7 and Stage III Prostate Cancer AJCC v7, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.
Primary Outcome
Will be defined as the ability to generate a microbial profile for \>= 80% of samples.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2026-07-29 |
What NCT04775355 shows while recruiting
NCT04775355 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 128-participant average among 5 other Stage IV Prostate Cancer AJCC v7 trials with a reported enrollment target (77% lower).
The record links to 6 conditions, with Stage IV Prostate Cancer AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04775355 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04775355 about?
NCT04775355 is a clinical study titled "Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer". This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to ...
What is the current status of trial NCT04775355?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2021-04-14. Estimated completion is 2026-07-29.
What conditions does trial NCT04775355 study?
This clinical trial studies the following conditions: Stage IV Prostate Cancer AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7, Stage I Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7.
What interventions are being tested in trial NCT04775355?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER).
Who is sponsoring clinical trial NCT04775355?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775355 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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