HistoMap AlloSure Renal Biopsies Observational Research Study - NCT07927374
The HistoMap AlloSure Renal Biopsies Observational Research Study (HARBOR) is a prospective, multicenter, observational cohort study of adult kidney transplant recipients undergoing a clinically indicated kidney allograft biopsy. The study will collect biospecimens and associated clinical data to support the development and evaluation of molecular approaches for assessing kidney allograft rejection. It will also examine relationships among histopathology, tissue-based gene expression profiling using HistoMap, donor-derived cell-free DNA (dd-cfDNA) measured using AlloSure, and clinical outcomes. As an observational study, HARBOR will not direct clinical care, and all diagnostic and treatment decisions will remain at the discretion of the treating clinicians in accordance with standard clinical practice.
- Company
- CareDx
- Keywords
- Kidney Transplant Rejection, T-Cell Mediated Rejection, Kidney Transplantation, Antibody Mediated Rejection, Kidney Transplantation, Kidney Allograft Rejection, Kidney Allograft Biopsy, Antibody-Mediated Rejection, T-Cell Mediated Rejection, Histopathology, Molecular Diagnostics, Donor-Derived Cell-Free DNA, AlloSure, HistoMap, Gene Expression Profiling, Biomarker Development, Transplant Monitoring, Kidney Allograft Dysfunction, Biospecimen Repository, Banff Classification, Donor-Specific Antibodies (DSA)