Bladder CancerNCT02203136
Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
An observational study of Bladder Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Tissue Biopsy and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2014to 16 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants scheduled for bladder cancer surgery and biopsy from the Department of Urology at MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- 1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment.
Who cannot join
- Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)
- Participants who have previously received chemotherapy as part of multimodal therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.
Read the detailed description
If participant agrees to take part in the study, a piece of the tumor that is removed during the biopsy will be collected for research purposes. The tissue will be sent to the laboratory for genetic testing.
If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan (MRI) recently, information collected from the scan will be collected. If they have not had one recently, they will have an MRI with contrast as part of this study. They will receive a separate consent form for this MRI scan.
The results of the test will be given to their doctor, but the results will not be used to decide their treatment.
After they have surgery, information will be collected from their medical records, such as their diagnosis.
Length of Study:
- Their participation on this study will be over once their surgery is completed.
- This is an investigational study.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Bladder Cancer
- Being tested
- Tissue Biopsy, Magnetic Resonance Imaging (MRI)
- Keywords
- Bladder cancer, Muscle invasive bladder cancer, MIBC, Biopsy specimen molecular profiling, Bladder surgery, Magnetic resonance imaging, MRI, Trans urethral resection of bladder
- 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.
Tissue BiopsyProcedure or surgery
During bladder cancer surgery, tissue specimen taken for molecular profiling.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Invasive Bladder Cancer (MIBC) | During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery. Receives: Procedure: Tissue Biopsy; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Improvement of Cancer Outside of the Bladder
Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study start25 Jun 2014
- Primary completion16 May 2019
- Study completion16 May 2019
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 M.D. Anderson 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Neema Navai, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203136
- Sponsor's protocol ID
- PA13-0942
- Status last verified
- May 2019
- First submitted
- 25 Jul 2014
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
- ClinicalTrials.gov ID
- NCT02203136
- Acronym / sponsor ID
- PA13-0942
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Muscle invasive bladder cancer, MIBC, Biopsy specimen molecular profiling, Bladder surgery, Magnetic resonance imaging, MRI, Trans urethral resection of bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 29 Jul 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.
The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.
Detailed description
If participant agrees to take part in the study, a piece of the tumor that is removed during the biopsy will be collected for research purposes. The tissue will be sent to the laboratory for genetic testing.
If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan (MRI) recently, information collected from the scan will be collected. If they have not had one recently, they will have an MRI with contrast as part of this study. They will receive a separate consent form for this MRI scan.
The results of the test will be given to their doctor, but the results will not be used to decide their treatment.
After they have surgery, information will be collected from their medical records, such as their diagnosis.
Length of Study:
- Their participation on this study will be over once their surgery is completed.
- This is an investigational study.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle Invasive Bladder Cancer (MIBC) | – | Procedure: Tissue Biopsy, Procedure: Magnetic Resonance Imaging (MRI)During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants scheduled for bladder cancer surgery and biopsy from the Department of Urology at MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (1 listed)
- 1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment.
Key exclusion criteria (2 listed)
- Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)
- Participants who have previously received chemotherapy as part of multimodal therapy.
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 |
|---|---|---|
| Tissue BiopsyDuring bladder cancer surgery, tissue specimen taken for molecular profiling. | Procedure or surgery | Muscle Invasive Bladder Cancer (MIBC) |
| Magnetic Resonance Imaging (MRI)Also: MRI3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery. | Procedure or surgery | Muscle Invasive Bladder Cancer (MIBC) |
Primary outcome
Detection Improvement of Cancer Outside of the Bladder
Time frame: 4 weeks
Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.
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 22 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Neema Navai, MD principal investigator
M.D. Anderson 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 M.D. Anderson 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 1 inclusion and 2 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 22 May 2019. 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?
Detection Improvement of Cancer Outside of the Bladder (time frame: 4 weeks). 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 22 May 2019.