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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04625556
Enrollment
3000
Registered
2020-11-12
Start date
2022-12-19
Completion date
2030-10-31
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between tissue bacteria composition and prevalence of urological malignancieswithin 2 weeks after the surgeryevaluate 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
Correlation between plasma bacteria composition and prevalence of urological malignancieswithin 2 weeks after the surgeryevaluate 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 malignancieswithin 2 weeks after the surgeryevaluate 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 urine bacteria composition and prevalence of urological malignancieswithin 2 weeks after the surgeryevaluate 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

Secondary

MeasureTime frameDescription
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 surgeryAssociation between bacteria composition and oncological prognosis, progression, and therapeutic response in urological malignancies

Countries

South Korea

Contacts

Primary ContactWon Sik Ham
uroham@yuhs.ac82-02-2228-2310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026