Currently submitted to: JMIR Research Protocols
Date Submitted: Jun 17, 2026
Open Peer Review Period: Jun 18, 2026 - Aug 13, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Prognostic Value of Epigenetic Biomarkers in Patients with Stage II Colorectal Cancer. Study protocol
ABSTRACT
Background:
Stage II colorectal cancer (CRC-II) represents a clinically heterogeneous group in which current clinicopathological criteria are insufficient for accurate recurrence risk stratification. Despite favorable outcomes after radical surgery, up to 30% of patients develop recurrence, which significantly worsens survival. Existing guidelines recommend adjuvant chemotherapy only for selected high-risk patients; however, these criteria lack specificity. Epigenetic biomarkers, particularly DNA methylation patterns, may improve prognostic accuracy and support personalized treatment decisions. This study is presented as a study protocol.
Objective:
This study aims to identify and validate epigenetic biomarkers associated with recurrence risk in patients with CRC-II and to develop a prognostic model for guiding personalized adjuvant therapy.
Methods:
This is a retrospective cohort study. The retrospective cohort (n=64) includes patients with stage II CRC who underwent radical surgery, with available tumor tissue and clinical follow-up data. DNA methylation profiling will be performed using Illumina Infinium MethylationEPIC v2 BeadChip arrays, enabling genome-wide assessment of over 850,000 CpG sites. Clinical, histopathological, and molecular data will be integrated. Statistical analysis will include logistic regression, ROC analysis, Kaplan–Meier survival analysis, Cox proportional hazards modeling, and false discovery rate correction to identify significant associations between methylation patterns and recurrence.
Results:
The study is currently ongoing. Retrospective data collection and analysis have been initiated. Results will include identification of methylation-based biomarkers associated with recurrence risk and development of a predictive model.
Conclusions:
This study is expected to improve risk stratification in CRC-II by integrating epigenetic biomarkers into prognostic models. The findings may support more precise selection of patients for adjuvant chemotherapy, potentially improving survival outcomes while reducing overtreatment. Clinical Trial: The study is ongoing.
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