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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625556
• Other study ID #: 4-2020-1018
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Prostate Cancer
• Renal Cell Cancer
• Ureter Cancer
• Ureteral Neoplasms
• Urological Malignancies

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