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Development of Urologic Registry for Personalized Medicine in Patients With Urological Malignancy by Analyzing Circulating Tumor DNA

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04197414
Collaborator
(none)
3,000
Enrollment
1
Location
119.9
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urological malignancies such as prostate cancer and renal cell cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of sequencing technologies, use of genetic mutation profiles in cancer detection and progression has been increased. However, use of circulating tumor DNA in urological malignances have been limited and few studies have been reported. Therefore, we tried to evaluate the usefulness of circulating tumor DNA in detection and monitoring of urological malignancies in Korean population. This study aims to use circulating tumor DNA in plasma and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for circulating tumor DNA of urological malignancies in Korean population and to develop optimized circulating tumor DNA platform.

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 Urological Malignancy by Analyzing Circulating Tumor DNA
    Actual Study Start Date :
    Dec 6, 2019
    Anticipated Primary Completion Date :
    Nov 1, 2029
    Anticipated Study Completion Date :
    Dec 1, 2029

    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 genetic mutations of circulating tumor DNA in plasma and urine samples and genetic mutations of primary tumor tissue samples [within 2 weeks after the surgery]

      evaluate mutation profiles of circulating tumor DNA in plasma and urine samples and associate with mutation profiles of primary tumor tissue samples : evaluate the mutation frequency of specific genes in both circulating tumor DNA in plasma and urine samples in association with primary tumor tissues

    Secondary Outcome Measures

    1. Correlation between circulating tumor DNA and early diagnosis and prognosis in urological malignancies [within 10 years after the surgery]

      evaluate the association of circulating tumor DNA and early diagnosis of urological malignancies : evaluate the association of circulating tumor DNA and early detection of recurrence : evaluate the association of circulating tumor DNA and cancer-specific survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
      1. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11
      1. Those who agree to give permission to use their human source information - 4. Those who agree with this study
    Exclusion Criteria:
      1. Those who do not agree with this study
      1. 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 Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04197414
    Other Study ID Numbers:
    • 4-2019-1039
    First Posted:
    Dec 13, 2019
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Dec 1, 2019
    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 Dec 13, 2019