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

Terminated

• Conditions: Stage I Bladder Cancer With Carcinoma In Situ; Stage I Bladder Urothelial Carcinoma; Stage II Bladder Urothelial Carcinoma; Stage III Bladder Urothelial Carcinoma; Stage 0a Bladder Urothelial Carcinoma; Stage 0is Bladder Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma; Bladder Papillary Urothelial Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT02494635
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Start: 2015-09-16
• Primary Completion: 2019-02-22
• Study Completion: 2019-02-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (ultrasound, biomarker studies)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
Observed change in fluorescence of responding cells using the cell response index (CRI)	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)	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States