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.

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Key information

Conditions

Prostate Cancer Adenocarcinoma Bladder Cancer Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Renal Cell Cancer Ureter Cancer Ureteral Diseases Ureteral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, 03722, South Korea

Location status: Recruiting

Location contact

Won Sik Ham, MD

CONTACT

[email protected]

82-2-2228-2310

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Correlation between genetic mutations of circulating tumor DNA in plasma and urine samples and genetic mutations of primary tumor tissue samples

Time frame: 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 outcomes

Correlation between circulating tumor DNA and early diagnosis and prognosis in urological malignancies

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Won Sik Ham

CONTACT

[email protected]

02-2228-2310

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2029
Study completion: 2029
First posted: Dec 13, 2019
Registry last updated: Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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