RecruitingNCT02379429

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

500 participants

Start Date

Nov 10, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tissue and blood samples from patients with bladder or urinary tract cancer — and from healthy volunteers — to better understand how the cancer develops and behaves, and to improve future treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with, or are suspected to have, bladder or urinary tract cancer and need a procedure (such as a biopsy or surgery) as part of your regular care - OR you are a healthy adult with no current cancer diagnosis and are willing to donate samples for research **You may NOT be eligible if...** - You are pregnant - You are currently being treated for another cancer (other than minor skin cancers) - You have a history of hepatitis B, hepatitis C, or HIV - As a healthy volunteer: you have significant heart, lung, or kidney disease, or you are a family member with a known inherited cancer gene mutation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02379429


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