Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of the miR Sentinel BCa™ Test to Diagnose Bladder Cancer in Hematuria Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155359
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
miR Scientific LLC

Brief Summary:
The purpose of the study is to establish the clinical performance and utility of the miR Sentinel™ BCa Test, a urine exosome-based diagnostic test, as an aid in diagnosing bladder cancer. Male and female participants presenting with micro- or macro-hematuria who are undergoing cystoscopy for diagnosis of bladder cancer will be eligible for the study. Urine samples will be collected at the time of the first presentation, and the miR Sentinel™ BCa Score determined and compared to the results of cystoscopy. Participants with no evidence of cancer following cystoscopy will be designated cancer-free, while those participants with a positive cystoscopy and histopathological evidence of cancer will be designated as having bladder cancer. Participants with a positive cystoscopy who subsequently undergo TURBT will be eligible to continue in the study. Urine samples will be collected at each follow up visit for up to three years, and the miR Sentinal™ BCR Score will be determined and compared to the results of surveillance cystoscopy.

Condition or disease
Bladder Cancer

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of the Performance of the miR Sentinel™ BCa Test in Men and Women Presenting for Initial Diagnosis of Bladder Cancer and the miR Sentinel™ BCR Test to Identify Recurrent Bladder Cancer
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To establish the performance characteristics of the miR Scientific Sentinel™ Bladder Cancer Diagnostic Test (miR Sentinel™ BCa Test), a urine exosome-based diagnostic test, to identify bladder cancer in participants presenting with hematuria [ Time Frame: Urine samples will be collected from participants at the time of entry and analyzed immediately for the miR Sentinel™ BCa test. Additional urine samples will be collected and analyzed at each follow-up visit up to 1 year. ]
    The miR Sentinel™ BCa test is an in-vitro urine exosome-based diagnostic test. The test measures up to 280 sncRNA present in urine exosomes and produces a dichotomized assessment of "-1" (no cancer) and "+1" (cancer) based on the expression profiles of the exosomal sncRNAs As outlined in detail in the statistical analysis of the description, among the 3000 participants (1500 males; 1500 females) enrolled, it is anticipated that 2600 (1275 males; 1325 females) will have a Sentinel™ BCa Score of "-1", indicative of no cancer , and 400 (225 males; 175 females) will have a Sentinel™ BCa Score of "+1", indicative of cancer. Concordance and discordance between the final Sentinel™ BCa Score and the histopathology reports of biopsy and cystoscopy results will be used to determine the sensitivity, specificity, positive and negative predictive values of the test.


Secondary Outcome Measures :
  1. Validate the performance characteristics of the miR Scientific Sentinel™ Bladder Cancer Recurrence Test (miR Sentinel™ BCR Test) for the identification of recurrent disease in a longitudinal study [ Time Frame: Urine samples will be collected from participants at entry, prior and post TURBT, given the miR Sentinel™ BCa test is "+1". Additional urine samples will be collected and analyzed at each follow-up visit, up to three years. ]
    The miR Sentinel™ BCR Test is an in-vitro urine exosome-based surveillance test that uses the same 280 sncRNAs a the miR Sentinel™ BCa Test, but uses a different importance weighting of individual sncRNA entities to produce a dichotomized miR Sentinel™ BCR Score of "-1" (no recurrence) and "+1" (recurrence) that predicts recurrence in participants previously diagnosed with bladder cancer following transurethral resection of bladder tumor (TURBT). Concordance and discordance between the final Sentinel™ BCR Score and the results of surveillance cystoscopy will be used to determine the sensitivity, specificity, positive and negative predictive values of the test.


Biospecimen Retention:   Samples Without DNA
Urine for Sentinel™ BCa Test


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 3000 participants (1500 males and 1500 females) will be enrolled from multi clinical site sin the U.S. and Canada. Participants will be males and females between the ages of 45 and 85 years presented with micro- or macro-hematuria, with cystoscopy as part of routine clinical workup for diagnosis of bladder cancer.
Criteria

Inclusion Criteria:

  • Males and females between the ages of 45 and 85 years of age
  • Signed informed consent prior to initiation of any study-related procedures
  • Minorities are included in this protocol
  • Micro- or macro-hematuria

Exclusion Criteria:

  • Persons incapable of providing informed consent
  • Any person with a prior history of bladder cancer
  • For continued enrollment in the validation of the miR SentinelMales and females between the ages of 45 and 85 years of age BCR Test, previous malignancies including bladder cancer, treatment with chemotherapeutic of immunotherapeutic agents
  • Persons with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome

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): NCT04155359


Contacts
Layout table for location contacts
Contact: Chief Scientific Officier, Ph.D. (518) 763-3779 martin.tenniswood@mirscientific.com
Contact: Director of Research, Ph.D. (518) 772-7792 winnie.wang@mirscientific.com

Locations
Layout table for location information
United States, New York
Integrated Medical Professionals
Farmington, New York, United States, 11743
Sponsors and Collaborators
miR Scientific LLC
Investigators
Layout table for investigator information
Principal Investigator: Carl A Olsson, MD Integrated Medical Professionals

Layout table for additonal information
Responsible Party: miR Scientific LLC
ClinicalTrials.gov Identifier: NCT04155359     History of Changes
Other Study ID Numbers: MIR-B001
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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