The Registry of Genetic Expression of Taiwan Urologic Cancer

National Health Research Institutes,Taiwan

This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma.

Study Overview

• Status: Recruiting
• Conditions: Urologic Cancer

Detailed Description

This project providing free and immediate next-generation gene sequencing testing for patients with urothelial and renal cell carcinomas that have is diagnosed or that have previously received systemic therapy. The goal of this project is to assist participating institutions in integrating next-generation sequencing results and building a real-time data storage and sharing platform, as well as establishing a tumor molecular biological atlas of Taiwanese patients with urothelial carcinoma and renal cell carcinoma. The data will be linked with clinical prognosis to facilitate the rapid screening of patients for effective potential therapeutic drugs and clinical trials, which is anticipated to prolong the survival rate of patients.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Wei-Lan Yu, B.S; Phone Number: 67658 886-2-23123456; Email: wlyu@nhri.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10048
    • Recruiting
    • Yu wei-lan
    • Contact: Tai-Lung Cha, MD, PhD; Phone Number: 18005 +886-2- 87923311; Email: Tailungcha@gmail.com
    • Contact: wei-lan Yu, College; Phone Number: 67658 +886-2-23123456; Email: wlyu@nhri.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

urothelial carcinoma and renal cell carcinoma

Description

Inclusion Criteria:

1. Ages 20 and above. (Age >= 18 years old from January 1, 2023).
2. Pathological reports showed renal cell carinoma or urothelial carcinoma.
3. muscle-invasive bladder cancer or positive of N/M grade, UTUC of T2 at least or positive of N/M grade, or stage III/IV RCC
4. Willingness to provide the residual biopsy/operative tumor samples for study.
5. Life expectancy more than 3 months.
6. Patients fully understand the protocol with the willingness to have regular follow-up.

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history.
2. Ineligible tumor tissue samples for next-generation sequencing of genetic testing.
3. Undesirable compliance.
4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
kidney cancer; RCC arms: Retrospective studies for ccRCC (N=100) and nccRCC (N=100). The studies aim to obtain clinical information to correlate with genetic characterization of RCCs of all types.
urothelial cancer; UC arm: This is a prospective study for UC originated from the translational epithelium in the urinary tract (N=300). The study aims to obtain cancer tissues that originated from bladder (N=100), ureter (N=100), and renal pelvis (N=100).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of an integrated database of genetic background	Development of an integrated database of genetic background from populations, underlying status, clinical information, and therapeutic outcomes in carcinogen-related advanced urologic tumors.	From date of registration to 30 Sep 2029

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Taiwan University Hospital; Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital; Taichung Veterans General Hospital; Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Tai-Lung Cha, MD, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms
• Other Study ID Numbers: T1822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be linked with clinical prognosis to facilitate the rapid screening of patients for effective potential therapeutic drugs and clinical trials, which is anticipated to prolong the survival rate of patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No