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

Recruiting

• Conditions: Prostate Cancer; Renal Cell Cancer; Ureter Cancer; Urological Malignancies; Bladder Cancer

• Registration Number: NCT04625556
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31
• Primary Completion: 2030-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between urine bacteria composition and prevalence of urological malignancies	within 2 weeks after the surgery	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
Correlation between plasma bacteria composition and prevalence of urological malignancies	within 2 weeks after the surgery	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
Correlation between stool bacteria composition and prevalence of urological malignancies	within 2 weeks after the surgery	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
Correlation between tissue bacteria composition and prevalence of urological malignancies	within 2 weeks after the surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of