Urologic CancerNCT05725304
The Registry of Genetic Expression of Taiwan Urologic Cancer
An observational study of Urologic Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Cancer
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jan 2023to 29 Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: urothelial carcinoma and renal cell carcinoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Health Research Institutes,Taiwan
This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma.
Read the 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.
- Conditions
- Urologic Cancer
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of registration to 30 Sep 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start7 Jan 2023
- Primary completion29 Oct 2029 (estimated)
- Study completion29 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University Chung-Ho Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Tai-Lung Cha, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725304
- Sponsor's protocol ID
- T1822
- Status last verified
- May 2025
- First submitted
- 2 Feb 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Health Research Institutes,Taiwan
- ClinicalTrials.gov ID
- NCT05725304
- Acronym / sponsor ID
- T1822
- Conditions
- Urologic Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 29 Oct 2029 (estimated)
- Study completion
- 29 Oct 2029 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- urothelial carcinoma and renal cell carcinoma
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of an integrated database of genetic background
Time frame: From date of registration to 30 Sep 2029
Development of an integrated database of genetic background from populations, underlying status, clinical information, and therapeutic outcomes in carcinogen-related advanced urologic tumors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Urologic Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tai-Lung Cha, MD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an integrated database of genetic background (time frame: From date of registration to 30 Sep 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.