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

NCT02379429 | Recruiting

• 2 other identifiers: 15008715-C-0087
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Urinary Tract Cancer; Urothelial Cancer; Healthy Volunteers

Keywords

Specimen Collection; Urine; Blood; Saliva; Natural History

Outcome Measures

Primary Outcomes (1)

• Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in urothelial cancer.

  Collection of blood, urine, saliva, and/or benign and malignant tissue

  ongoing

Secondary Outcomes (3)

• Perform molecular profiling and analysis to better characterize urothelial cancer and identify novel targets.

  ongoing

• Develop stable urothelial / bladder cancer cell lines from procured tissue when feasible.

  ongoing

• Collect detailed history, pathologic data, perioperative findings, and treatment data to better characterize the natural and clinical histories of urothelial cancer when feasible.

  ongoing

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two different groups of population: 1. 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 2. Healthy volunteers (18 and older),the specimens will provide appropriate controls for comparison.

You may qualify if:

• Adults (\>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
• ECOG performance status of 0-3.
• Must be willing and able to provide informed consent.

You may not qualify if:

• Subjects who are pregnant.
• Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:
• Ongoing treatment for another non-skin malignancy.
• History of hepatitis B/C or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
• ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS
• Adults (greater than or equal to 18 years of age) and able to give informed consent.
• Subjects who are pregnant.
• Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.
• Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.
• History of acute or chronic hepatitis B/C or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
• Healthy volunteers who are family members with germline mutations.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Raju R Chelluri, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidenys C O'Brien Gutierrez

CONTACT

(240) 858-7481; lidenys.o'brien@nih.gov

Raju R Chelluri, M.D.

CONTACT

(240) 858-3700; raju.chelluri@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 5, 2015
• Study Start: November 10, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03-31

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)