Bladder CancerNCT02053662
Biomarker Identification for Bladder Cancer Patients
An observational study of Bladder Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Sample Collection
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2014to 16 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected muscle-invasive bladder cancer and appropriate control population
Who may be able to join
- Adult patients ≥18 years old.
- Patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer.
- Patients undergoing cystoscopy without cancer suspicion.
- Ability to give an informed consent.
Who cannot join
- Patients receiving concurrent therapy for a second malignancy.
- < 18 years old.
- Inability to give an informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. This will include looking for changes in proteins and genes that might play a role in bladder cancer biology. The investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. The knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.
- Conditions
- Bladder Cancer
- Being tested
- Sample Collection
- Keywords
- Bladder Cancer
- 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.
Sample CollectionProcedure or surgery
A collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Patients | Patients with muscle invasive bladder cancer. A sample collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed. Receives: Procedure: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify novel biomarkers for bladder cancer
Predict and detect bladder cancer recurrence, specifically through development of biomarkers using bladder cancer tissue samples as well as blood and urine samples. Detect the recurrence of disease through development of blood and urine biomarkers using pre-therapy and post-therapy biospecimens.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start21 Jan 2014
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Why it stopped: No publishable data was acquired from the study and the primary researcher left over 5 years ago.
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 Ohio State University Comprehensive Cancer CenterThe 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
- 179 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnab Chakravarti, Ohio State University Comprehensive Cancer Center
- Investigators
- Arna Chakravarti, MD, Principal investigator, The Ohio State University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053662
- Sponsor's protocol ID
- OSU-12158
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2014
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Identification for Bladder Cancer Patients
- ClinicalTrials.gov ID
- NCT02053662
- Acronym / sponsor ID
- OSU-12158
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No publishable data was acquired from the study and the primary researcher left over 5 years ago.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. This will include looking for changes in proteins and genes that might play a role in bladder cancer biology. The investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. The knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patients | – | Procedure: Sample CollectionPatients with muscle invasive bladder cancer. A sample collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected muscle-invasive bladder cancer and appropriate control population
Key inclusion criteria (4 listed)
- Adult patients ≥18 years old.
- Patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer.
- Patients undergoing cystoscopy without cancer suspicion.
- Ability to give an informed consent.
Key exclusion criteria (3 listed)
- Patients receiving concurrent therapy for a second malignancy.
- < 18 years old.
- Inability to give an informed consent.
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 |
|---|---|---|
| Sample CollectionA collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed. | Procedure or surgery | Bladder Cancer Patients |
Primary outcome
Identify novel biomarkers for bladder cancer
Time frame: up to 5 years
Predict and detect bladder cancer recurrence, specifically through development of biomarkers using bladder cancer tissue samples as well as blood and urine samples. Detect the recurrence of disease through development of blood and urine biomarkers using pre-therapy and post-therapy biospecimens.
Results and safety
The study was stopped early (reason given: No publishable data was acquired from the study and the primary researcher left over 5 years ago.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- The JameslineLink provided by the sponsor.
- 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.
Arna Chakravarti, MD principal investigator
The Ohio State University Cancer Center
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 Ohio State University Comprehensive Cancer Center 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 3 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: stopped early, as of the sponsor's last update on 21 Mar 2025. 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 was stopped early (reason given: No publishable data was acquired from the study and the primary researcher left over 5 years ago.). Results are not available in the source record.
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?
Identify novel biomarkers for bladder cancer (time frame: up to 5 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 21 Mar 2025.