Actively Recruiting

Age: 18Years - 120Years
All Genders
Healthy Volunteers
ID02379429

Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients

Led by National Cancer Institute (NCI) · Updated on 2026-04-02

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Urothelial cancer affects the bladder, ureter, and urethra, and researchers aim to understand the cellular and genetic changes that cause this cancer to develop. This knowledge may help identify new treatment options. The study focuses on collecting and analyzing tissue and other biological samples to explore molecular differences between normal and tumor tissues, and to predict disease progression and treatment responses. Participants include adults with biopsy-proven or suspected urothelial cancer, as well as healthy volunteers. Patients will undergo diagnostic or therapeutic procedures as part of their standard care, during which tissue samples may be collected and stored in a tissue bank. Blood, urine, and saliva samples will also be collected from both patients and healthy volunteers. No experimental treatments are given; care follows medically indicated standards. During the study, participants will have physical exams, medical record reviews, and sample collections including blood, urine, saliva, and tissue. Patients may have imaging scans and follow-up visits every six months, with ongoing health status updates collected by phone. Researchers will analyze these samples and clinical data to study the molecular mechanisms of urothelial cancer and develop potential new therapies. Participation may last several years, with ongoing sample and data collection.

CONDITIONS

Brief Title

Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue

Who Can Participate

Age: 18Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with biopsy-proven or suspected urothelial cancer who require diagnostic or therapeutic intervention
  • ECOG performance status of 0-3
  • Willing and able to provide informed consent
  • Healthy volunteers aged 18 years or older able to give informed consent
Not Eligible

You will not qualify if you...

  • Pregnant individuals
  • Patients with co-morbidities that prevent diagnostic or therapeutic intervention, including ongoing treatment for another non-skin malignancy
  • History of hepatitis B, hepatitis C, or HIV infection
  • Healthy volunteers with cancer requiring treatment other than minor basal or squamous cell skin cancer resection
  • Healthy volunteers with heart, lung, kidney disease, or other medical conditions as determined by the principal investigator
  • Healthy volunteers who are family members with germline mutations

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Variable depending on clinical care

Participants with suspected or confirmed urothelial cancer undergo diagnostic or therapeutic interventions as part of routine care, during which tissue samples may be collected.

Visits occur as part of routine clinical diagnostic or therapeutic procedures

Surveillance

Duration - Ongoing throughout the study

Participants with urothelial cancer and healthy volunteers provide blood, urine, and saliva samples at baseline and during follow-up intervals for research purposes.

Baseline sample collection and additional follow-up sample collections as per clinical visits

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

L

Lidenys C O'Brien Gutierrez

R

Raju R Chelluri, M.D.

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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Frequently Asked Questions

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