Urine Omics Predicting IO Therapy Responses in mUC Patients
NCT ID: NCT04641936
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2020-12-17
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No intervention required
No intervention required
Cohort B
Validation cohort will be recruited in the next 36 months of the study period.
No intervention required
No intervention required
Interventions
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No intervention required
No intervention required
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
20 Years
MALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yeong Shiau Pu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202010097RINC
Identifier Type: -
Identifier Source: org_study_id
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