The Registry of Genetic Expression of Taiwan Urologic Cancer

Study Overview
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Brief Summary
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This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma.

Detailed Description
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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.

Official Title
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National Health Research Institutes,Taiwan

Conditions
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Urologic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 20 and above. (Age >= 18 years old from January 1, 2023). Pathological reports showed renal cell carinoma or urothelial carcinoma. 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 Willingness to provide the residual biopsy/operative tumor samples for study. Life expectancy more than 3 months. Patients fully understand the protocol with the willingness to have regular follow-up. Exclusion Criteria: Inability to cooperate by providing a complete medical history. Ineligible tumor tissue samples for next-generation sequencing of genetic testing. Undesirable compliance. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| kidney cancer<br>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<br>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?
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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 |