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

NCT ID: NCT04197414

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-06

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer Renal Cell Cancer Bladder Cancer Ureter Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate cancer

Patients diagnosed as prostate cancer and have undergone prostatectomy

No interventions assigned to this group

Renal cell cancer

Patients diagnosed as renal cell cancer and have undergone partial or radical nephrectomy

No interventions assigned to this group

Bladder cancer

Patients diagnosed as bladder cancer and have undergone radical or partial cystectomy

No interventions assigned to this group

Ureter cancer

Patients diagnosed as ureter cancer and have undergone nephroureterectomy or ureterectomy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Won Sik Ham

Role: CONTACT

Phone: 02-2228-2310

Email: [email protected]

Facility Contacts

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Won Sik Ham, MD

Role: primary

Other Identifiers

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4-2019-1039

Identifier Type: -

Identifier Source: org_study_id