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

January 30, 2023 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Won Sik Ham
  • Phone Number: 82-02-2228-2310
  • Email: uroham@yuhs.ac

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone surgeries with urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) in Severance Hospital, Sinchon from 2020.10 and 2030.10 were selected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prostate cancer
Patients diagnosed as prostate cancer and have undergone prostatectomy
Renal cell cancer
Patients diagnosed as renal cell cancer and have undergone partial or radical nephrectomy
Bladder cancer
Patients diagnosed as bladder cancer and have undergone radical or partial cystectomy
Ureter cancer
Patients diagnosed as ureter cancer and have undergone nephroureterectomy or ureterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tissue bacteria composition and prevalence of urological malignancies
Time Frame: 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
within 2 weeks after the surgery
Correlation between plasma bacteria composition and prevalence of urological malignancies
Time Frame: 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
within 2 weeks after the surgery
Correlation between stool bacteria composition and prevalence of urological malignancies
Time Frame: 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
within 2 weeks after the surgery
Correlation between urine bacteria composition and prevalence of urological malignancies
Time Frame: 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
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)
Time Frame: within 10 years after the surgery
Association between bacteria composition and oncological prognosis, progression, and therapeutic response in urological malignancies
within 10 years after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Won Sik Ham, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Anticipated)

October 1, 2030

Study Completion (Anticipated)

October 1, 2030

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2020-1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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