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Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02494635
Recruitment Status : Terminated (The PI left institution)
First Posted : July 10, 2015
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
University of Southern California

Brief 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. 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.

Condition or disease Intervention/treatment
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 Stage III Bladder Urothelial Carcinoma Stage IV Bladder Urothelial Carcinoma Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. 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).


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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness
Actual Study Start Date : September 16, 2015
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Laboratory Biomarker Analysis
Biomarker analysis




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Tissue, bladder washings, and urine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494635


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Andres Weitz University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02494635     History of Changes
Other Study ID Numbers: 4B-15-5
NCI-2015-00862 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-15-00245
4B-15-5 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
P41EB002182 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases