Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorYonsei University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 4 trial groupsGroup A: Prostate cancer
Group B: Renal cell cancer
Group C: Bladder cancer
Group D: Ureter cancer
Trial outcomes
Primary outcomes
1
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
Time frame
within 2 weeks after the surgery2
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
Time frame
within 2 weeks after the surgery3
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
Time frame
within 2 weeks after the surgery4
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
Time frame
within 2 weeks after the surgerySecondary outcomes
1
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
Time frame
within 10 years after the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov