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

NCT04155359 | Unknown DMC

• 1 other identifier: MIR-B001
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (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

  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.

  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.

Secondary Outcomes (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

  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.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• miR Scientific LLC: lead

Study Sites (1)

Integrated Medical Professionals

Farmingdale, New York, 11735, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine for Sentinel™ BCa Test

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

Study Officials

• Carl A Olsson, MD

  Integrated Medical Professionals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: October 13, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

US (1)