The Registry of Genetic Expression of Taiwan Urologic Cancer

National Health Research Institutes, Taiwan

Status: Active, not recruiting

Conditions: Urologic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05725304

T1822

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

kidney cancer

Description:

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

Description:

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).