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

NCT04197414 | Recruiting

• 1 other identifier: 4-2019-1039
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Renal Cell Cancer; Bladder Cancer; Ureter Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  within 10 years after the surgery

Study Arms (4)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
• \. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11
• \. Those who agree to give permission to use their human source information - 4. Those who agree with this study

You may not qualify if:

• \. Those who do not agree with this study
• \. Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

frozen tissue, blood, and urine samples

MeSH Terms

Conditions

Prostatic Neoplasms; Carcinoma, Renal Cell; Urinary Bladder Neoplasms; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Won Sik Ham

CONTACT

02-2228-2310; uroham@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: December 6, 2019
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)