NCT02494635

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

Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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
• Stage III Bladder Urothelial Carcinoma
• Stage IV Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Biomarker analysis

Timeline

• Start date: 2015-09-16
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2015-07-10
• Last updated: 2019-07-08

Locations

1 site across 1 country: United States