Clinical trial NCT02494635: Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer
Official title: Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2015-07-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.

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).

Eligibility 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

Primary outcomes:
measure: Observed change in fluorescence of responding cells using the cell response index (CRI)
timeFrame: Baseline to up to 30 minutes
measure: Observed change in percentage of responding cells using the cell response index (CRI)
timeFrame: Baseline to up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Andres Weitz
role: PRINCIPAL_INVESTIGATOR
References: