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BRIEF TITLE: Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness

Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness


  • Org Study ID: 4B-15-5
  • Secondary ID: NCI-2015-00862,HS-15-00245,4B-15-5,P30CA014089,P41EB002182
  • NCT ID: NCT02494635
  • NCT Alias:
  • Sponsor: University of Southern California - Other
  • Source: 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).

Overal Status Start Date Phase Study Type
Recruiting September 16, 2015 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Observed change in fluorescence of responding cells using the cell response index (CRI)

Primary Outcome 1 - Time Frame: Baseline to up to 30 minutes

Primary Outcome 2 - Measure: Observed change in percentage of responding cells using the cell response index (CRI)

Primary Outcome 2 - Time Frame: Baseline to up to 30 minutes

Condition:

  • 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

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Andres Weitz

Role: Principal Investigator

Affiliation: University of Southern California

Overall Contact

Name: Ileana Aldana

Phone: 323-865-0702

Email: Ileana.aldana@med.usc.edu

Location

Facility Status Contact
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Andres Weitz
323-865-0648
aweitz@usc.edu