Bladder Papillary Urothelial CarcinomaNCT02494635
Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer
An observational study of Bladder Papillary Urothelial Carcinoma and Stage 0a Bladder Urothelial Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Papillary Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2015to 22 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.
Who may be able to join
- Patients with a confirmed diagnosis of UCC, having one of the stages (Ta, Tis, T1, and T2 or higher)
- Patients with UCC who are undergoing a standard procedure to remove cells/tissue from their bladders (cystoscopy, biopsy, or surgery)
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness
This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. This may allow doctors to predict how likely the cancer cells are to spread in the body. The biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. Comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish an association between bladder cancer disease stage and the level of invasiveness as measured by a novel ultrasound assay.
II. To establish an association between bladder cancer disease stage and expression of novel invasiveness biomarkers related to the RE1-silencing transcription factor (REST) gene.
OUTLINE:
Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), Western blot, and fluorescence in situ hybridization (FISH).
- Conditions
- Bladder Papillary Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Cancer With Carcinoma In Situ, Stage I Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma
- Being tested
- Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Biomarker analysis
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound, biomarker studies) | Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via qRT-PCR, Western blot, and FISH. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed change in fluorescence of responding cells using the cell response index (CRI)
Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response.
Measured: Baseline to up to 30 minutes
Observed change in percentage of responding cells using the cell response index (CRI)
Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response.
Measured: Baseline to up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start16 Sep 2015
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Why it stopped: The PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Papillary Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Andres Weitz, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494635
- Sponsor's protocol ID
- 4B-15-5
- Other IDs
- NCI-2015-00862, HS-15-00245, 4B-15-5, P30CA014089, P41EB002182
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness
- ClinicalTrials.gov ID
- NCT02494635
- Acronym / sponsor ID
- 4B-15-5
- Conditions
- Bladder Papillary Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Cancer With Carcinoma In Situ, Stage I Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI left institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 10 Jul 2015 (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.
This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. This may allow doctors to predict how likely the cancer cells are to spread in the body. The biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. Comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.
Detailed description
PRIMARY OBJECTIVES:
- To establish an association between bladder cancer disease stage and the level of invasiveness as measured by a novel ultrasound assay.
II. To establish an association between bladder cancer disease stage and expression of novel invasiveness biomarkers related to the RE1-silencing transcription factor (REST) gene.
OUTLINE:
Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), Western blot, and fluorescence in situ hybridization (FISH).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound, biomarker studies) | – | Other: Laboratory Biomarker AnalysisPreviously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via qRT-PCR, Western blot, and FISH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.
Key inclusion criteria (3 listed)
- Patients with a confirmed diagnosis of UCC, having one of the stages (Ta, Tis, T1, and T2 or higher)
- Patients with UCC who are undergoing a standard procedure to remove cells/tissue from their bladders (cystoscopy, biopsy, or surgery)
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (1 listed)
- Patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
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 |
|---|---|---|
| Laboratory Biomarker AnalysisBiomarker analysis | Other | Diagnostic (ultrasound, biomarker studies) |
Primary outcome
Observed change in fluorescence of responding cells using the cell response index (CRI)
Time frame: Baseline to up to 30 minutes
Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response.
Observed change in percentage of responding cells using the cell response index (CRI)
Time frame: Baseline to up to 30 minutes
Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response.
Results and safety
The study was stopped early (reason given: The PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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.
Andres Weitz principal investigator
University of Southern California
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 Papillary Urothelial Carcinoma and Stage 0a Bladder Urothelial Carcinoma, run by University of Southern California 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 3 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: stopped early, as of the sponsor's last update on 8 Jul 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 was stopped early (reason given: The PI left institution). 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?
Observed change in fluorescence of responding cells using the cell response index (CRI) (time frame: Baseline to up to 30 minutes). The study lists 2 primary outcomes in all. 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 8 Jul 2019.