The Registry of Genetic Expression of Taiwan Urologic Cancer

NCT ID: NCT05725304

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-07

Study Completion Date

2029-10-29

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.

Conditions

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Urologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tai-Lung Cha, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Yu wei-lan

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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T1822

Identifier Type: -

Identifier Source: org_study_id

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