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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Mar 4, 2015

Keywords

ClinConnect Summary

This clinical trial is studying how urothelial cancer, which affects the bladder and other parts of the urinary system, develops and changes at the cellular level. Researchers aim to analyze tissue samples from patients with this type of cancer to understand the differences between healthy and cancerous cells. By looking at DNA and other molecular changes, they hope to find better ways to treat the disease and predict how it may progress in different patients.

To participate, you must be an adult aged 18 or older who has been diagnosed with or is suspected of having urothelial cancer. Healthy volunteers are also welcome, but they must not have any significant health issues or a history of cancer. Participants will undergo several tests, including physical exams and providing tissue samples, which may be used for future research. If you need surgery for your cancer, some of the tissue will be kept for study. Throughout the trial, participants will have follow-up appointments to provide health updates. This research is important as it seeks to improve understanding and treatment options for bladder cancer.

Gender

ALL

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.