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BRIEF TITLE: PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance

A Pilot Study to Evaluate the PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance


  • Org Study ID: VBRm BCA-01
  • Secondary ID:
  • NCT ID: NCT04756284
  • NCT Alias:
  • Sponsor: PhageTech, Inc. - Industry
  • Source: PhageTech, Inc.

Brief Summary

To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

Detailed Description


This study will sample urine provided by bladder cancer patients as part of their normal
routine surveillance screening. No additional effort will be required from the patients and
only modest additional effort from the study staff. Some de-identified patient medical
information may also be requested, including concominant medications, relevant current or
previous diseases, prior bladder cancer interventions and other relevant information to
ensure there are no interfering substances or other confounders that could affect study
results. There is no risk to patients as the normal diagnostics for bladder cancer will be
followed.

Overal Status Start Date Phase Study Type
Recruiting February 8, 2021 Observational [Patient Registry]

Primary Outcomes:

Primary Outcome 1 - Measure: Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance

Primary Outcome 1 - Time Frame: Up to 1 year

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Male and female patients ≥ 18 years

2. Previous bladder cancer diagnosis; any stage and histological type, undergoing
cystoscopy

3. Patients with suspected bladder tumor undergoing surveillance cystoscopy

4. Patients must provide written Informed Consent.

Exclusion Criteria:

1. Patients unable or unwilling to sign the informed consent

2. Age < 18 years

3. Known HIV/HCV/HBV (information from clinical history).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Name: Rodney Brenneman

Phone: 949-433-6007

Email: rbrenneman@phagetech.com

Location

Facility Status Contact
Providence Saint John's Health Center and the Saint John's Cancer Institute
Santa Monica, California 90404
United States
Recruiting Lisa van Kreuningen, M.S.
310-582-7053
lisa.vankreuningen@providence.org