Evaluation of the PhageTech Virus BioResistor

PhageTech

Status: Unknown

Conditions: Bladder Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04756284

VBRm BCA-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

50 participants in 2 patient groups

Bladder Tumor Positive

Description:

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

Bladder Tumor Negative

Description:

Patients with no suspected bladder tumor.