Mass Spectrometry in Single Bladder Cancer Cells

University of Oklahoma (OU)

Status: Completed

Conditions: Bladder Cancer

Treatments: Diagnostic Test: mass spectrometry

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03639090

1R21CA204706-01 (U.S. NIH Grant/Contract)

Mass Spectrometry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 30 to 99 years old

Volunteers: No Healthy Volunteers

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.