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

Recruiting

• Conditions: Bladder Cancer; Prostate Cancer; Ureter Cancer; Renal Cell Cancer

• Registration Number: NCT04197414
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-06
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13
• Primary Completion: 2029-11
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 1. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
• 2. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11
• 3. 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
• 2. Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine; 🇰🇷 Seoul, Korea, Republic of