Clinical trial NCT05725304: The Registry of Genetic Expression of Taiwan Urologic Cancer
Official title: National Health Research Institutes,Taiwan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urologic Cancer
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Taiwan University Hospital
name: Tri-Service General Hospital
name: Chang Gung Memorial Hospital
name: Taichung Veterans General Hospital
name: Kaohsiung Veterans General Hospital.
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
First posted: 2023-02-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: urothelial carcinoma and renal cell carcinoma

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of an integrated database of genetic background
timeFrame: From date of registration to 30 Sep 2029
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yu wei-lan
Study officials:
affiliation: Tri-Service General Hospital
name: Tai-Lung Cha, MD
role: PRINCIPAL_INVESTIGATOR
References: