Bladder Cancer Clinical Trial
Official title:
Mass Spectrometry Detection of Drugs in Single Bladder Cancer Cells From Patients
Verified date | October 2020 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study is a pilot study in the feasibility of a diagnostic technique. There is no current data on detection of cisplatin in cancer cells derived from human urine. This study will generate preliminary data so that future studies may be done with more definitive end points in mind.
Status | Completed |
Enrollment | 2 |
Est. completion date | October 8, 2020 |
Est. primary completion date | October 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Patients must have a diagnosis of bladder cancer 2. Patients must be undergoing their first cycle of cisplatin based chemotherapy due to metastatic disease or as pre-operative treatment before cystectomy 3. Patients with a diagnosis of bladder cancer who will not be undergoing chemotherapy 4. Patients must have demonstrated positive urinary cytology prior to inclusion in the study Exclusion Criteria: 1. Patients who do not have bladder cancer. |
Country | Name | City | State |
---|---|---|---|
United States | University of Oklahoma HSC, Department of Urology | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of the intracellular concentration | An instrument to determine the concentration of therapeutic agent will be used. Results of the test will be used to determine feasibility of this technique for application in personalized chemotherapy dosing and treatment monitoring in the future. For each patient sample, the concentration of cisplatin will be measured in several different cells, as many as 10 depending upon the characteristics of the sample. The results of each individual run of the test will be recorded for the purpose of verifying internal consistency of the technique. Measurement will be first in relative mass of the agent to other known controls which will be used to calculate the approximate cellular concentration of cisplatin. Refining the technique for estimating the concentration is one of the goals of the project. | 4 years |
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