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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197414
• Other study ID #: 4-2019-1039
• Status: Recruiting
• Start date: December 6, 2019
• Est. completion date: December 2029

Study information

• Verified date: December 2019
• Source: Yonsei University
• Contact: Won Sik Ham
• Phone: 02-2228-2310
• Email: uroham[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Prostate Cancer
• Renal Cell Cancer
• Ureter Cancer
• Ureteral Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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