Clinical trial NCT04625556: Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
Official title: Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urological Malignancies
Prostate Cancer
Renal Cell Cancer
Bladder Cancer
Ureter Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Correlation between tissue bacteria composition and prevalence of urological malignancies
timeFrame: within 2 weeks after the surgery
measure: Correlation between plasma bacteria composition and prevalence of urological malignancies
timeFrame: within 2 weeks after the surgery
measure: Correlation between stool bacteria composition and prevalence of urological malignancies
timeFrame: within 2 weeks after the surgery
measure: Correlation between urine bacteria composition and prevalence of urological malignancies
timeFrame: within 2 weeks after the surgery
Secondary outcomes:
measure: Correlation of bacteria composition and tumor response assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
timeFrame: within 10 years after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Won Sik Ham
role: PRINCIPAL_INVESTIGATOR
References: