Metastatic Urothelial CarcinomaNCT04641936
Urine Omics Predicting IO Therapy Responses in mUC Patients
An observational study of Metastatic Urothelial Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Metastatic Urothelial Carcinoma
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Dec 2020to 31 Oct 2027
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Advanced and metastatic UC patients who will receive IO-based therapy.
Who may be able to join
- 1. Age > 20 years
- 2. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
- 3. Subjects who are about to receive IO-based therapy
- 4. ECOG performance 0, 1, 2, and 3
- 5. Life expectancy 3 months
- 6. eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
- 7. Willing to sign the informed consent form
Who cannot join
- 1. Subjects NOT willing to sign the informed consent form
- 2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
- 3. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
- 4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- 5. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
- 6. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yeong-Shiau Pu, MD PhD, 886-2-23123456 ext. 65254, pu5249@ntuh.gov.tw
Chung-Hsin Chen, MD PhD, 886-2-23123456 ext. 65242, mufasachen@gmail.com
About this study
Official title: Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.
Read the detailed description
This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
- Conditions
- Metastatic Urothelial Carcinoma
- Being tested
- No intervention required
- Keywords
- urothelial carcinoma, biomarkers, clinical responses, IO-based therapies, metabolomics, proteomics, Urine
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention requiredOther
No intervention required
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers. Receives: Other: No intervention required | |
| Cohort B | Validation cohort will be recruited in the next 36 months of the study period. Receives: Other: No intervention required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 7 years
Progression-free survival (PFS)
Measured: 7 years
Duration of response (DOR)
Measured: 7 years
Overall survival (OS)
Measured: 7 years
Adverse event of special interest (AESI)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start17 Dec 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong Shiau Pu, MD PhD, Principal investigator, Department of Urology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641936
- Sponsor's protocol ID
- 202010097RINC
- Status last verified
- Apr 2024
- First submitted
- 18 Nov 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04641936
- Acronym / sponsor ID
- 202010097RINC
- Conditions
- Metastatic Urothelial Carcinoma
- Keywords
- urothelial carcinoma, biomarkers, clinical responses, IO-based therapies, metabolomics, proteomics, Urine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Nov 2020 (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.
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.
Detailed description
This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: No intervention requiredTraining cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers. |
| Cohort B | – | Other: No intervention requiredValidation cohort will be recruited in the next 36 months of the study period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced and metastatic UC patients who will receive IO-based therapy.
Key inclusion criteria (7 listed)
- 1. Age > 20 years
- 2. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
- 3. Subjects who are about to receive IO-based therapy
- 4. ECOG performance 0, 1, 2, and 3
- 5. Life expectancy 3 months
Key exclusion criteria (6 listed)
- 1. Subjects NOT willing to sign the informed consent form
- 2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
- 3. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
- 4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- 5. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention requiredNo intervention required | Other | Cohort A, Cohort B |
Primary outcome
Objective Response Rate (ORR)
Time frame: 7 years
Progression-free survival (PFS)
Time frame: 7 years
Duration of response (DOR)
Time frame: 7 years
Overall survival (OS)
Time frame: 7 years
Adverse event of special interest (AESI)
Time frame: 7 years
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Yeong Shiau Pu, MD PhD principal investigator
Department of Urology, National Taiwan University Hospital
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 Metastatic Urothelial Carcinoma, run by National Taiwan University Hospital 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Apr 2024. 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?
Contact Yeong Shiau Pu, MD PhD (886-2-23123456 ext. 65254, pu5249@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 7 years). The study lists 5 primary outcomes in all. 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 17 Apr 2024.