Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome

Study Overview
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Brief Summary
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Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of technologies, studies have found that microbiome not only affects human physiological functions, such as metabolism, immunity, and haematopoiesis, but also plays a significant role in the development and progression of malignancies. However, the investigation of microbiome in urological malignances have been limited and few studies have been reported. Therefore, the investigator tried to evaluate the usefulness of microbiome in detection and monitoring of urological malignancies in Korean population. This study aims to use microbiome in tissue, plasma, stool and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for microbiome of urological malignancies in Korean population.

Official Title
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Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome

Conditions
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Urological Malignancies, Prostate Cancer, Renal Cell Cancer, Bladder Cancer, Ureter Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2020.10 and 2030.10 Those who agree to give permission to use their human source information Those who agree with this study Exclusion Criteria: Those who do not agree with this study Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer<br>Patients diagnosed as prostate cancer and have undergone prostatectomy | |
| Renal cell cancer<br>Patients diagnosed as renal cell cancer and have undergone partial or radical nephrectomy | |
| Bladder cancer<br>Patients diagnosed as bladder cancer and have undergone radical or partial cystectomy | |
| Ureter cancer<br>Patients diagnosed as ureter cancer and have undergone nephroureterectomy or ureterectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between tissue bacteria composition and prevalence of urological malignancies | evaluate and compare the bacteria composition in tissue samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group | within 2 weeks after the surgery | 
| Correlation between plasma bacteria composition and prevalence of urological malignancies | evaluate and compare the bacteria composition in plasma samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group | within 2 weeks after the surgery | 
| Correlation between stool bacteria composition and prevalence of urological malignancies | evaluate and compare the bacteria composition in stool samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group | within 2 weeks after the surgery | 
| Correlation between urine bacteria composition and prevalence of urological malignancies | evaluate and compare the bacteria composition in urine samples in urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) with healthy control group | within 2 weeks after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of bacteria composition and tumor response assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Association between bacteria composition and oncological prognosis, progression, and therapeutic response in urological malignancies | within 10 years after the surgery |