MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools. Patients scheduled for one of 10 different Heart Failure surgical / interventional therapies will be identified and consented. Four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. Blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (PBMC's) will be isolated. The PBMC samples will be shipped to ResearchDx, Irvine, CA, for testing using the MyLeukoMAP™ genomic survival prediction assay. Patient 1-year postoperative survival/non-survival data will be reported for each patient. The samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. The investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools. ;

Study Design

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT05258942
Study type	Observational
Source	LeukoLifeDx Inc
Contact	Simran Prajapat, PhD
Phone	617.820.3725
Email	sprajapat@researchdx.com
Status	Recruiting
Phase
Start date	July 1, 2022
Completion date	August 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.