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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02379429
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 10, 2015
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 1/Participants
    Adults with biopsy-proven or suspected urothelial cancer who require diagnostic or therapeutic intervention
  • Arm: 2/Healthy Volunteers
    Healthy volunteers from whom blood, saliva and urine samples are easily obtainable.

Primary Outcome Measure

Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in urothelial cancer. [ Time Frame: ongoing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies