Locally Advanced or Metastatic Urothelial CarcinomaNCT07072637
Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy
An observational study of Locally Advanced or Metastatic Urothelial Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Carcinoma
- What is being tested?
- Neurological function assessment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2025to 31 Dec 2031
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age ≥ 20 years) with histologically confirmed locally advanced or metastatic urothelial carcinoma who are planned to receive EV-based therapy. Participants must be eligible for neurological assessments and able to provide informed consent.
Who may be able to join
- Age ≥ 20 y/o
- Histologically confirmed urothelial carcinoma
- Radiologically documented locally advanced or metastatic disease
- Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)
- Complete and identifiable medical records
Who cannot join
- Do not agree to receive regular neurological examinations
- Do not agree to provide complete medical records during treatment
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
National Taiwan University Hospital
Taipei
Fu-Jen Hsueh, M.D., 02-23123456 ext. 66001, 017052@ntuh.gov.tw
Fu-Jen Hsueh, M.D.
About this study
Official title: A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy
This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.
Read the detailed description
Peripheral neuropathy (PN) is a frequent and often debilitating adverse event associated with enfortumab vedotin (EV), a NECTIN-4-directed antibody-drug conjugate approved for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). While EV has demonstrated significant antitumor efficacy, the objective assessment of PN and its clinical implications remain insufficiently explored. This prospective observational study aims to comprehensively evaluate neurological function and its correlation with subjective PN symptoms in la/mUC patients receiving EV-based therapy.
A total of 100 patients will be prospectively enrolled between March 2025 and December 2029. Neurological assessments will include neurological neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These evaluations will be conducted at baseline and every three months until six months post-EV treatment. Clinical data, including patient characteristics and oncologic outcomes, will also be collected.
This study aims to identify predictive factors for EV-related PN and to evaluate the broader clinical implications of neurological function changes. The ultimate goal is to inform strategies for toxicity mitigation and to optimize therapeutic outcomes and quality of life in la/mUC patients.
- Being tested
- Neurological function assessment
- Keywords
- enfortumab vedotin, urothelial carcinoma, neurological function
- 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.
Neurological function assessmentDiagnostic test
Neurological evaluations including neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. Assessments will be conducted at baseline and every three months until six months after completion of EV treatment.
| Study group | Role | What they receive |
|---|---|---|
| EV-based therapy | Patients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy Receives: Diagnostic Test: Neurological function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between neurological function and subjective peripheral neuropathy symptoms
Correlation between objective neurological assessments (nerve conduction study, QST, autonomic function tests, TCNS) and patient-reported peripheral neuropathy symptoms.
Measured: Baseline to 6 months post-treatment.
Secondary outcomes (1)
Correlation between neurological function changes and oncological outcomes
To evaluate whether the degree or pattern of neurological function changes (e.g., worsening in NCS, QST) correlates with clinical efficacy measures such as objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
Measured: From date of EV initiation to the date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study startJul 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072637
- Sponsor's protocol ID
- 202502005RINB
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy
- ClinicalTrials.gov ID
- NCT07072637
- Acronym / sponsor ID
- 202502005RINB
- Keywords
- enfortumab vedotin, urothelial carcinoma, neurological function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 Jul 2025 (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 prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.
Detailed description
Peripheral neuropathy (PN) is a frequent and often debilitating adverse event associated with enfortumab vedotin (EV), a NECTIN-4-directed antibody-drug conjugate approved for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). While EV has demonstrated significant antitumor efficacy, the objective assessment of PN and its clinical implications remain insufficiently explored. This prospective observational study aims to comprehensively evaluate neurological function and its correlation with subjective PN symptoms in la/mUC patients receiving EV-based therapy.
A total of 100 patients will be prospectively enrolled between March 2025 and December 2029. Neurological assessments will include neurological neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These evaluations will be conducted at baseline and every three months until six months post-EV treatment. Clinical data, including patient characteristics and oncologic outcomes, will also be collected.
This study aims to identify predictive factors for EV-related PN and to evaluate the broader clinical implications of neurological function changes. The ultimate goal is to inform strategies for toxicity mitigation and to optimize therapeutic outcomes and quality of life in la/mUC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EV-based therapy | – | Diagnostic Test: Neurological function assessmentPatients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age ≥ 20 years) with histologically confirmed locally advanced or metastatic urothelial carcinoma who are planned to receive EV-based therapy. Participants must be eligible for neurological assessments and able to provide informed consent.
Key inclusion criteria (5 listed)
- Age ≥ 20 y/o
- Histologically confirmed urothelial carcinoma
- Radiologically documented locally advanced or metastatic disease
- Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)
- Complete and identifiable medical records
Key exclusion criteria (2 listed)
- Do not agree to receive regular neurological examinations
- Do not agree to provide complete medical records during treatment
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 |
|---|---|---|
| Neurological function assessmentNeurological evaluations including neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. Assessments will be conducted at baseline and every three months until six months after completion of EV treatment. | Diagnostic test | EV-based therapy |
Primary outcome
Correlation between neurological function and subjective peripheral neuropathy symptoms
Time frame: Baseline to 6 months post-treatment.
Correlation between objective neurological assessments (nerve conduction study, QST, autonomic function tests, TCNS) and patient-reported peripheral neuropathy symptoms.
1 secondary outcome
Correlation between neurological function changes and oncological outcomes
Time frame: From date of EV initiation to the date of death from any cause, assessed up to 36 months
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 18 Jul 2025.
- 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.
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 Locally Advanced or 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 18 Jul 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?
Contact Fu-Jen Hsueh, M.D. (02-23123456 ext. 66001, 017052@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between neurological function and subjective peripheral neuropathy symptoms (time frame: Baseline to 6 months post-treatment.). 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 18 Jul 2025.