The Registry of Genetic Expression of Taiwan Urologic Cancer

Urologic Cancer Clinical Trial

Official title:

National Health Research Institutes,Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725304
• Other study ID #: T1822
• Status: Recruiting
• Start date: January 7, 2023
• Est. completion date: September 30, 2029

Study information

• Verified date: March 2024
• Source: National Health Research Institutes, Taiwan
• Contact: Wei-Lan Yu, B.S
• Phone: 886-2-23123456
• Email: wlyu[@]nhri.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urologic Cancer
• Urologic Neoplasms

Locations

Country	Name	City	State
Taiwan	Yu wei-lan	Taipei

Sponsors (8)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., National Taiwan University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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