Actively Recruiting

Age: 18Years - 120Years
All Genders
Healthy Volunteers
NCT02379429

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

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

500

Participants Needed

1

Research Sites

633 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it. Objective: \- To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy. Eligibility: \- Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer. Design: * Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed. * Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank. * Participants medical records may be reviewed. * Participants may have a medical history and physical exam. * Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research. * If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research. * Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits. * Participants will be called every 6 months to give health updates.

CONDITIONS

Official 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 18 years of age or older with biopsy-proven or suspected urothelial cancer who require or are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance
  • ECOG performance status of 0 to 3
  • Willing and able to provide informed consent
  • Healthy volunteers 18 years or older able to give informed consent
Not Eligible

You will not qualify if you...

  • Pregnant subjects
  • Subjects 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 who are family members with germline mutations
  • Healthy volunteers with heart, lung, kidney disease, or other medical conditions as determined by the Principal Investigator
  • Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

R

Raju R Chelluri, M.D.

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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