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Trial Title:
The Registry of Genetic Expression of Taiwan Urologic Cancer
NCT ID:
NCT05725304
Condition:
Urologic Cancer
Conditions: Official terms:
Urologic Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
urothelial carcinoma and renal cell carcinoma
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yu wei-lan
Address:
City:
Taipei
Zip:
10048
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
wei-lan Yu, College
Phone:
+886-2-23123456
Phone ext:
67658
Email:
wlyu@nhri.org.tw
Contact backup:
Last name:
Tai-Lung Cha, MD, PhD
Phone:
+886-2- 87923311
Phone ext:
18005
Email:
Tailungcha@gmail.com
Start date:
January 7, 2023
Completion date:
September 30, 2029
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Collaborator:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Tri-Service General Hospital
Agency class:
Other
Collaborator:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Taichung Veterans General Hospital
Agency class:
Other
Collaborator:
Agency:
Kaohsiung Veterans General Hospital.
Agency class:
Other
Collaborator:
Agency:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05725304