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@ARTICLE{Truong:301368,
author = {T. T. Truong and K. Mikloska and J. Sum and M. Oberländer
and N. von Bubnoff and L. Christiansen and S. Tornow and S.
Derer and F. Janke$^*$ and H. Sültmann$^*$ and S. Zeissig
and M. Linnebacher and C. Schafmayer and M. Lehnert and T.
Hutzenlaub and N. Paust and P. Juelg},
title = {{C}oupling {I}mmunoprecipitation with {M}ultiplexed
{D}igital {PCR} for {C}ell-{F}ree {DNA} {M}ethylation
{D}etection in {S}mall {P}lasma {V}olumes of {E}arly-{O}nset
{C}olorectal {C}ancer.},
journal = {Analytical chemistry},
volume = {97},
number = {21},
issn = {0003-2700},
address = {Columbus, Ohio},
publisher = {American Chemical Society},
reportid = {DKFZ-2025-01006},
pages = {11259-11268},
year = {2025},
note = {2025 Jun 3;97(21):11259-11268},
abstract = {Colorectal cancer (CRC) remains a major global health
challenge, with an increasing incidence of early-onset cases
among young adults. Targeted analysis of cell-free DNA
(cfDNA) methylation in blood has emerged as a promising
minimally invasive diagnostic approach. While digital PCR
(dPCR) offers high sensitivity and low turnaround times,
conventional bisulfite-based dPCR assays require large
plasma volumes due to cfDNA degradation, limiting clinical
feasibility. To overcome this limitation, we developed a
bisulfite-free, low-plasma-volume assay by coupling
cell-free methylated DNA immunoprecipitation (cfMeDIP) with
multiplexed dPCR for methylation detection. Assays were
designed for CRC targets based on publicly available
bisulfite-based plasma data and optimized for native,
bisulfite-untreated cfDNA. The cfMeDIP-dPCR assays were
first developed and optimized on circulating tumor DNA
surrogates derived from HCT116 cells and subsequently
validated in a pilot study, including 32 early-onset CRC
(EO-CRC) patients and 29 non-CRC individuals. Methylation
ratios, defined as the proportion of methylated to total
cfDNA copies per marker, served as a diagnostic indicator.
Three out of four selected markers (SEPT9, KCNQ5, and
C9orf50) were successfully adapted, with significantly
higher methylation ratios (p ≤ 0.001) in the EO-CRC
cohort. KCNQ5 demonstrated the highest diagnostic
performance, achieving an $85\%$ sensitivity at a $90\%$
specificity, with methylation ratios correlating with the
tumor stage. This study presents the first cfMeDIP-dPCR
approach, demonstrating its potential as a sensitive liquid
biopsy assay. Requiring only 0.5 mL of plasma, i.e., more
than 20 times less than a sensitivity-matched
bisulfite-based assay, cfMeDIP-dPCR facilitates clinical
implementation for CRC and other diseases with epigenetic
signatures.},
cin = {B063},
ddc = {540},
cid = {I:(DE-He78)B063-20160331},
pnm = {312 - Funktionelle und strukturelle Genomforschung
(POF4-312)},
pid = {G:(DE-HGF)POF4-312},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:40380352},
doi = {10.1021/acs.analchem.5c01361},
url = {https://inrepo02.dkfz.de/record/301368},
}