Methylated cfDNA detection in renal transplant patients
Research type
Research Study
Full title
Development of a detection method for methylated donor derived cell free DNA to increase the sensitivity of this non-invasive biomarker for transplant rejection.
IRAS ID
347541
Contact name
Delordson Kallon
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The detection of rejection early in solid organ transplantation is critical in preventing failure of the transplanted organ and managing the patient post-transplant. The current gold-standard test for this is a tissue biopsy of the transplanted organ in combination with a range of markers such as serum creatinine and HLA antibodies to monitor suspected rejection. However the tissue biopsy is not without risk: it is an invasive procedure requiring penetration of the transplanted organ with a needle to extract tissue that can be stained and analysed, pain and bleeding complications are commonly documented post-biopsy and the procedure is not only costly to the NHS but can be impractical if repeat procedures are necessary.
The liquid biopsy is an emerging assay that is showing promise in detecting rejection and is a less painful non-invasive method which can be collected easily irrespective of the target organ. It involves testing the proportion of donor DNA in a recipient blood sample and therefore is easily repeatable and less expensive compared to a tissue biopsy. Although large studies have shown this assay to detect rejection, the sensitivity and specificity of the test could still be improved ( % and % respectively).
The detection of epigenetic changes of DNA have also been used in the early detection of cancers and more recently in solid organ transplant rejection. Thus by combining the two techniques and detecting epigenetic changes in donor DNA present in the recipient blood, a more sensitive and specific test could become the new gold-standard and potentially replace the need for a tissue biopsy.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0041
Date of REC Opinion
21 Mar 2025
REC opinion
Further Information Favourable Opinion