Evaluation of the PhageTech Virus BioResistor

February 12, 2021 updated by: PhageTech, Inc.

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Saint John's Health Center and the Saint John's Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhageTech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 8, 2021

Primary Completion (ANTICIPATED)

November 11, 2021

Study Completion (ANTICIPATED)

November 11, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBRm BCA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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