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

INTRODUCTION

  • Org Study ID: VBRm BCA-01
  • Secondary ID: N/A
  • NTC ID: NCT04756284
  • Sponsor: 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.

  • Overall Status
    Recruiting
  • Start Date
    February 8, 2021
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to 1 year

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Male and female patients ≥ 18 years

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

- Patients with suspected bladder tumor undergoing surveillance cystoscopy

- Patients must provide written Informed Consent.
Exclusion Criteria:
Patients unable or unwilling to sign the informed consent

- Age < 18 years - Known HIV/HCV/HBV (information from clinical history).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 949-433-6007

Email: rbrenneman@phagetech.com

LOCATION

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