The Registry of Genetic Expression of Taiwan Urologic Cancer

NCT05725304 | Active Not Recruiting DMC

• 1 other identifier: T1822
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

urothelial carcinoma and renal cell carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: collaborator
• Tri-Service General Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• Kaohsiung Veterans General Hospital.: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (1)

Yu wei-lan

Taipei, 10048, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

more than 30% of tumor compartments tissue. RCC arms (N=200): ccRCC (N=100) and nccRCC (N=100) or UC 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).

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Officials

• Tai-Lung Cha, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: January 7, 2023
• Primary Completion (Estimated): October 29, 2029
• Study Completion (Estimated): October 29, 2029
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)