Bladder CancerNCT03639090
Mass Spectrometry in Single Bladder Cancer Cells
An observational study of Bladder Cancer, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 99 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- mass spectrometry
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 8 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bladder cancer at Stephenson Cancer who are undergoing treatment with cisplatin are eligible to participate.
Who may be able to join
- 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
- Patients must have demonstrated positive urinary cytology prior to inclusion in the study
Who cannot join
- 1. Patients who do not have bladder cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma HSC, Department of Urology
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- mass spectrometry
- Keywords
- chemotherapy, mass spectrometry
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mass spectrometryDiagnostic test
mass spectrometry for bladder cancer cells
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jul 2017
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Heinlen, M.D., Principal investigator, University of Oklahoma HSC, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639090
- Sponsor's protocol ID
- Mass Spectrometry
- Other IDs
- 1R21CA204706-01
- Status last verified
- Oct 2020
- First submitted
- 24 Jul 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Spectrometry Detection of Drugs in Single Bladder Cancer Cells From Patients
- ClinicalTrials.gov ID
- NCT03639090
- Acronym / sponsor ID
- Mass Spectrometry
- Conditions
- Bladder Cancer
- Keywords
- chemotherapy, mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bladder cancer at Stephenson Cancer who are undergoing treatment with cisplatin are eligible to participate.
Key inclusion criteria (4 listed)
- 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
- Patients must have demonstrated positive urinary cytology prior to inclusion in the study
Key exclusion criteria (1 listed)
- 1. Patients who do not have bladder cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mass spectrometrymass spectrometry for bladder cancer cells | Diagnostic test | – |
Primary outcome
Measurement of the intracellular concentration
Time frame: 4 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Heinlen, M.D. principal investigator
University of Oklahoma HSC, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the intracellular concentration (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.