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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04625556
Other study ID # 4-2020-1018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 19, 2022
Est. completion date October 2030

Study information

Verified date January 2023
Source Yonsei University
Contact Won Sik Ham
Phone 82-02-2228-2310
Email uroham@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date October 2030
Est. primary completion date October 2030
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Locations

Country Name City State
Korea, Republic of Yonsei Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
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