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NCT Number: NCT04625556

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

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.

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Key information

Conditions

Urological Malignancies Adenocarcinoma Bladder Cancer Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Cell Cancer Ureter Cancer Ureteral Diseases Ureteral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Won Sik Ham

CONTACT

[email protected]

82-02-2228-2310

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Nov 12, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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