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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adults (greater than or equal to 18 years of age) and able to give informed consent.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Sonia E Bellfield, R.N.
sonia.bellfield@nih.gov
(240) 760-6118
Backup
Raju R Chelluri, M.D.
raju.chelluri@nih.gov
(240) 858-3700
Time Frame
Start Date: 2015-11-10
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 500
Treatments
1/Participants
Adults with biopsy-proven or suspected urothelial cancer who require diagnostic or therapeutic intervention
2/Healthy Volunteers
Healthy volunteers from whom blood, saliva and urine samples are easily obtainable.
Authors
Vladimir A Valera Romero, Piyush K Agarwal
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov