Actively Recruiting

Age: 20Years +
MALE
NCT04641936

Urine Omics Predicting IO Therapy Responses in mUC Patients

Led by National Taiwan University Hospital · Updated on 2024-04-17

600

Participants Needed

1

Research Sites

358 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Urine Omics Predicting IO Therapy Responses in mUC Patients

Who Can Participate

Age: 20Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

Y

Yeong Shiau Pu, MD PhD

CONTACT

C

Chung Hsin Chen, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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