Mass Spectrometry in Single Bladder Cancer Cells

NCT03639090 | Completed

• 2 other identifiers: Mass Spectrometry1R21CA204706-01
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

chemotherapy, mass spectrometry

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

mass spectrometry DIAGNOSTIC_TEST

mass spectrometry for bladder cancer cells

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients must have a diagnosis of bladder cancer
• Patients must be undergoing their first cycle of cisplatin based chemotherapy due to metastatic disease or as pre-operative treatment before cystectomy
• Patients with a diagnosis of bladder cancer who will not be undergoing chemotherapy

You may not qualify if:

• \. Patients who do not have bladder cancer.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Oklahoma HSC, Department of Urology

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample, blood sample

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Heinlen, M.D.

  University of Oklahoma HSC, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 20, 2018
• Study Start: July 1, 2017
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)