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

NCT04625556 | Recruiting

• 1 other identifier: 4-2020-1018
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urological Malignancies; Prostate Cancer; Renal Cell Cancer; Bladder Cancer; Ureter Cancer

Outcome Measures

Primary Outcomes (4)

• 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

  within 2 weeks after the surgery

• 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

  within 2 weeks after the surgery

• 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

  within 2 weeks after the surgery

• 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

  within 2 weeks after the surgery

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)

  within 10 years after the surgery

Study Arms (4)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

frozen tissue, blood, stool, and urine samples

MeSH Terms

Conditions

Prostatic Neoplasms; Carcinoma, Renal Cell; Urinary Bladder Neoplasms; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases; Ureteral Diseases

Study Officials

• Won Sik Ham

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Sik Ham

CONTACT

82-02-2228-2310; uroham@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 12, 2020
• Study Start: December 19, 2022
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)