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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04197414
Enrollment
3000
Registered
2019-12-13
Start date
2019-12-06
Completion date
2029-12-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Prostate Cancer, Renal Cell Cancer, Ureter Cancer

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between genetic mutations of circulating tumor DNA in plasma and urine samples and genetic mutations of primary tumor tissue sampleswithin 2 weeks after the surgeryevaluate 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

MeasureTime frameDescription
Correlation between circulating tumor DNA and early diagnosis and prognosis in urological malignancieswithin 10 years after the surgeryevaluate 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

Countries

South Korea

Contacts

Primary ContactWon Sik Ham
uroham@yuhs.ac02-2228-2310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026