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

NCT02494635 | Terminated DMC

• 5 other identifiers: 4B-15-5NCI-2015-00862HS-15-00245P30CA014089P41EB002182
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Observed change in fluorescence of responding cells using the cell response index (CRI)

  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.

  Baseline to up to 30 minutes

• Observed change in percentage of responding cells using the cell response index (CRI)

  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.

  Baseline to up to 30 minutes

Study Arms (1)

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

Interventions

Laboratory Biomarker Analysis OTHER

Biomarker analysis

Diagnostic (ultrasound, biomarker studies)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, bladder washings, and urine

Study Officials

• Andres Weitz

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 10, 2015
• Study Start: September 16, 2015
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

US (1)