Evaluation of the PhageTech Virus BioResistor

NCT04756284 | Unknown

• 1 other identifier: VBRm BCA-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance

  Up to 1 year

Study Arms (2)

Bladder Tumor Positive

Patients with previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy or suspected bladder tumor undergoing surveillance cystoscopy.

Bladder Tumor Negative

Patients with no suspected bladder tumor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort or samples will be required from the patients. Results from this study will not be used for any of the normal physician diagnostic process. Patients will have a suspected bladder tumor undergoing cystoscopy or a history of bladder cancer undergoing surveillance cystoscopy. Patients who have had a positive diagnosis of bladder cancer, but have not yet had a tumor resection (known BCa positive patients) are highly desirable for this study. It is anticipated that the majority of samples collected will be negative. In the case of a known BCa positive patient, the sponsor is requested

You may qualify if:

• 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.

You may not qualify if:

• Patients unable or unwilling to sign the informed consent
• Age \< 18 years
• Known HIV/HCV/HBV (information from clinical history).

Sponsors & Collaborators

• PhageTech, Inc.: lead

Study Sites (1)

Providence Saint John's Health Center and the Saint John's Cancer Institute

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Rodney Brenneman

CONTACT

949-433-6007; rbrenneman@phagetech.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: February 8, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

US (1)