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Trial record 1 of 1 for:    04756284
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Evaluation of the PhageTech Virus BioResistor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04756284
Recruitment Status : Unknown
Verified February 2021 by PhageTech, Inc..
Recruitment status was:  Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
PhageTech, Inc.

Study Description
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Brief Summary:
To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

Condition or disease
Bladder Cancer

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: A Pilot Study to Evaluate the PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance
Estimated Study Start Date : February 8, 2021
Estimated Primary Completion Date : November 11, 2021
Estimated Study Completion Date : November 11, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance [ Time Frame: Up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04756284


Contacts
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Contact: Rodney Brenneman 949-433-6007 rbrenneman@phagetech.com

Locations
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United States, California
Providence Saint John's Health Center and the Saint John's Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Lisa van Kreuningen, M.S.    310-582-7053    lisa.vankreuningen@providence.org   
Sponsors and Collaborators
PhageTech, Inc.
More Information
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Responsible Party: PhageTech, Inc.
ClinicalTrials.gov Identifier: NCT04756284    
Other Study ID Numbers: VBRm BCA-01
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases