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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Won Sik Ham; Phone Number: 02-2228-2310; Email: uroham@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
    • Contact: Won Sik Ham, MD; Phone Number: 82-2-2228-2310; Email: uroham@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 2019.12 and 2029.11 were selected.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between genetic mutations of circulating tumor DNA in plasma and urine samples and genetic mutations of primary tumor tissue samples	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	within 2 weeks after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between circulating tumor DNA and early diagnosis and prognosis in urological malignancies	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	within 10 years after the surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Anticipated): November 1, 2029
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Ureteral Diseases; Carcinoma, Renal Cell; Ureteral Neoplasms
• Other Study ID Numbers: 4-2019-1039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No