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

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04625556
Collaborator
(none)
3,000
Enrollment
1
Location
119
Anticipated Duration (Months)
25.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome
    Anticipated Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2030
    Anticipated Study Completion Date :
    Oct 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between tissue bacteria composition and prevalence of urological malignancies [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

    2. Correlation between plasma bacteria composition and prevalence of urological malignancies [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

    3. Correlation between stool bacteria composition and prevalence of urological malignancies [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

    4. Correlation between urine bacteria composition and prevalence of urological malignancies [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

    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) [within 10 years after the surgery]

      Association between bacteria composition and oncological prognosis, progression, and therapeutic response in urological malignancies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Won Sik Ham, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04625556
    Other Study ID Numbers:
    • 4-2020-1018
    First Posted:
    Nov 12, 2020
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Ureteral Neoplasms

    Study Results

    No Results Posted as of Nov 13, 2020