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

University of Southern California

Status: Terminated

Conditions: Stage I Bladder Cancer With Carcinoma In Situ; Stage 0is Bladder Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma; Stage I Bladder Urothelial Carcinoma; Stage III Bladder Urothelial Carcinoma; Stage 0a Bladder Urothelial Carcinoma; Stage II Bladder Urothelial Carcinoma; Bladder Papillary Urothelial Carcinoma

Treatments: Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02494635

P41EB002182 (U.S. NIH Grant/Contract)

HS-15-00245

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2015-00862 (Registry Identifier)

4B-15-5 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4 participants in 1 patient group

Diagnostic (ultrasound, biomarker studies)

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis