Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.
Pancreatic cancer is a digestive system malignancy characterized by late clinical detection, high malignancy, and poor prognosis. Exploring economically viable, accurate, and minimally invasive methods for early diagnosis and postoperative monitoring is of significant clinical importance to facilitate early screening and improve patient outcomes. Liquid biopsy, which involves detecting various tumor-related biomarkers in extractable bodily fluids, such as circulating tumor cells, circulating tumor DNA, and exosomes, plays a crucial role in the early diagnosis and prognosis of pancreatic cancer. Recent research indicates the substantial impact of liquid biopsy in the early diagnosis and prognosis of pancreatic cancer. Differential methylation regions in ctDNA, as opposed to ctDNA mutations, show promise as potential markers. Aberrant DNA methylation has been demonstrated to be more frequent than DNA mutations in tumor development and often occurs early in carcinogenesis. In this project, whole-genome methylation signal scans are conducted on blood samples and tumor tissue samples from pancreatic cancer using next-generation sequencing. The goal is to identify tumor-specific methylation biomarker sites. Subsequently, targeted sequencing is performed on ctDNA based on these identified sites.
Study Type
OBSERVATIONAL
Enrollment
1,000
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGSensitivity and Specificity of ctDNA in Early Screening for Pancreatic Cancer
Measured using a targeted DNA methylation panel for ctDNA in plasma. The presence or absence of cancer will be confirmed by histopathological diagnosis. Sensitivity and specificity will be calculated using standard diagnostic test evaluation against the gold-standard diagnosis. "Early-stage" is defined as stage I or II pancreatic cancer confirmed by imaging and pathology.
Time frame: Up to 2 years from start of study
Sensitivity and Specificity of ctDNA Methylation Test for Detection of Postoperative Recurrence
Measured using plasma ctDNA methylation profiles collected at scheduled postoperative time points (e.g., every 3 months). Recurrence will be confirmed by imaging (CT/MRI) or biopsy when clinically indicated. Diagnostic accuracy (sensitivity/specificity) will be evaluated by comparing ctDNA results to confirmed recurrence status.
Time frame: Up to 2 years from start of study
Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment
PFS will be calculated from the date of enrollment to the date of disease progression or death from any cause. Disease progression will be assessed using RECIST 1.1 criteria via CT/MRI scans performed every 3-6 months.
Time frame: Up to 3 years from start of study
Overall Survival (OS)
Overall survival will be defined as the time from enrollment to death from any cause. Survival status will be monitored every 3 months through clinic visits or phone follow-up.
Time frame: Up to 3 years from start of study
Early and Late Imaging Data
CT and/or MRI imaging will be used to measure tumor size, vascular invasion, and metastasis at baseline and every 3-6 months. Data will be used to assess tumor response, progression, or recurrence.
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Time frame: Up to 3 years from start of study
Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer
Serum levels of CA19-9 and CEA will be measured at baseline and during follow-up visits using standard immunoassays. Biomarker trends will be analyzed to assess correlation with disease stage, treatment response, and recurrence.
Time frame: Up to 3 years from start of study