Mass Spectrometry in Single Bladder Cancer Cells

Mass Spectrometry Detection of Drugs in Single Bladder Cancer Cells From Patients

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: mass spectrometry

Detailed Description

The aim of this study is to determine the feasibility of using a novel mass spectrometry instrument to measure the intracellular concentration of chemotherapeutic drug within an active tumor cell. If successful, this technique could be applied to dosage streamlining in patients and customization of dosage based on individual tumor characteristics. It also opens the door to research on novel chemotherapy agents or agents not typically used in a specific malignancy to determine if therapeutic levels can be obtained in tumor cells.

Personalized chemotherapy is an evolving field with the underlying goal being minimization of side effects of treatment while maximizing net patient benefit for therapy. A key difficulty in personalized chemotherapy is that the determination of therapeutic benefit comes well after the administration of treatment has been completed. For most forms of chemotherapy there does not exist a laboratory study that can determine the concentration of therapeutic agent within the tumor itself and as such, real time dose adjustments are based only on toxicity, not on tumor penetrance.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma HSC, Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with bladder cancer at Stephenson Cancer who are undergoing treatment with cisplatin are eligible to participate.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jonathan Heinlen, M.D., University of Oklahoma HSC, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 8, 2020
• Study Completion (Actual): October 8, 2020

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: chemotherapy, mass spectrometry
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: Mass Spectrometry; 1R21CA204706-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No