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

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


  • Org Study ID: 150087
  • Secondary ID: 15-C-0087
  • NCT ID: NCT02379429
  • NCT Alias:
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: National Institutes of Health Clinical Center (CC)

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.

Detailed Description


Background:

- Urothelial carcinoma, present as lower or upper urinary tract disease, is the most
expensive malignancy to treat from diagnosis to death, and no major advances in drug
therapy have taken place in the last two decades.

- Understanding the molecular mechanisms and genomic alterations that cause urothelial
carcinoma will provide the foundation for the development of novel targeted therapeutic
agents for this disease. Since 1982 investigators in the Urologic Oncology Branch have
been studying the genetic basis of urologic cancers. The identification of the genes for
cancer of the kidney has led to the approval by the FDA of a number of new agents for
patients with advanced disease. Similarly, it is our goal to study the cancer biology
(genomic, molecular, and cellular biology) of urothelial carcinoma in order to develop
novel treatment strategies.

- Collection of patient tumor samples allows us to study molecular and biologic pathways
and develop novel targeted therapies. Correlation of these samples with clinical
outcomes in patients allows us to predict and understand clinical outcomes and possibly
develop predictive and/or prognostic biomarkers.

- Collection of blood, urine and saliva from healthy volunteers will allow us to
distinguish normal and inflammatory conditions from malignant diseases. Furthermore, the
specimens will provide appropriate controls for comparison.

Objective (Primary):

- Collect blood, urine, and benign and malignant tissue from patients with known or
suspected urothelial cancer for the purpose of elucidating the molecular mechanisms of
carcinogenesis in urothelial cancer and ultimately, identifying novel therapeutic
targets.

- Collect blood, urine and saliva from healthy volunteers for the purpose of establishing
controls for comparison with urothelial cancer specimens.

Eligibility:

- Adults with biopsy-proven or suspected urothelial cancer who require diagnostic or
therapeutic intervention as part of their diagnosis, standard of care treatment, or
followup/surveillance for their neoplasm.

- Healthy volunteers from whom blood, saliva and urine samples are easily obtainable.

Design:

- Care of the patient with urothelial carcinoma will be provided as per medically
indicated standards and in the process, normal and malignant urothelial cancer tissues
may be obtained at the time of clinically indicated diagnostic and/or therapeutic
intervention.

- Blood, urine, and saliva samples for research may be obtained from patients and healthy
volunteers at baseline. Additionally, blood and urine may be collected from patients at
follow-up intervals.

- No investigational or experimental therapy will be given as part of this protocol.

Overal Status Start Date Phase Study Type
Recruiting Start Date: February 20, 2015 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in urothelial cancer

Primary Outcome 1 - Time Frame: Ongoing

Condition:

  • Bladder Cancer
  • Urinary Tract Cancer
  • Urothelial Cancer
  • Healthy Volunteers

Eligibility

Criteria:
- INCLUSION CRITERIA:

- 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.

ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS (NCI ONLY)

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.

- Healthy volunteers who are family members with germline mutations.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Piyush K Agarwal, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: Sonia E Bellfield, R.N.

Phone: (240) 760-6118

Email: sonia.bellfield@nih.gov

Link: NIH Clinical Center Detailed Web Page

Location

Facility Status Contact
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892
United States
Recruiting For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937