Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urological Malignancies, Prostate Cancer, Renal Cell Cancer, Bladder Cancer. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Correlation between tissue bacteria composition and prevalence of urological malignancies [Time frame: within 2 weeks after the surgery]
- Correlation between plasma bacteria composition and prevalence of urological malignancies [Time frame: within 2 weeks after the surgery]
- Correlation between stool bacteria composition and prevalence of urological malignancies [Time frame: within 2 weeks after the surgery]
- Correlation between urine bacteria composition and prevalence of urological malignancies [Time frame: within 2 weeks after the surgery]
Secondary outcome measures (1)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Yonsei Severance Hospital — Seoul
Identifiers
NCT: NCT04625556 · 4-2020-1018