Understanding Urothelial Cancer through Tissue Collection

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

This study is collecting tissue and other samples from people with urothelial cancer to see how the disease works and to help find better treatments.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02379429 on ClinicalTrials.gov

What this trial studies

This study aims to collect and analyze tissue samples from patients with urothelial cancer to better understand the genetic and molecular changes associated with the disease. Participants will provide tumor tissue blocks, blood, urine, and saliva samples, which will be used to identify differences between normal and cancerous tissues. The research focuses on the potential development of targeted therapies and predictive biomarkers for urothelial cancer. Healthy volunteers will also contribute samples for comparison purposes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have or are suspected of having urothelial cancer.

Not a fit: Patients who are pregnant or have co-morbidities that prevent diagnostic or therapeutic intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to new treatment strategies and improved outcomes for patients with urothelial cancer.

How similar studies have performed: Other studies focusing on the genetic basis of cancers have shown success in identifying new treatment pathways, suggesting this approach has potential.

Eligibility criteria

* INCLUSION CRITERIA FOR UROTHELIAL CANCER PARTICIPANTS:
* 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.

EXCLUSION CRITERIA:

* 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

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Raju R Chelluri, M.D. — National Cancer Institute (NCI)
• Study coordinator: Lidenys C O'Brien Gutierrez

Conditions: Bladder Cancer, Urinary Tract Cancer, Urothelial Cancer, Healthy Volunteers, Specimen Collection, Urine, Blood, Saliva