Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma
Sponsor study identifier
observational
1,000
1 country
1
Study Start
October 30, 2022
Actual (reported)Primary Completion
January 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2022
Actual (reported)May 8, 2025
Actual (reported)July 1, 2025
Actual (reported)January 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity 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.
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.
Up to 2 years from start of study
Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment
Up to 3 years from start of study
Overall Survival (OS)
Up to 3 years from start of study
Early and Late Imaging Data
Up to 3 years from start of study
Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer
Up to 3 years from start of study
benign pancreatic lesions
malignant pancreatic lesions
The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Wu Y, Seufert I, Al-Shaheri FN, Kurilov R, Bauer AS, Manoochehri M, Moskalev EA, Brors B, Tjaden C, Giese NA, Hackert T, Buchler MW, Hoheisel JD. DNA-methylation signature accurately differentiates pancreatic cancer from chronic pancreatitis in tissue and plasma. Gut. 2023 Nov 24;72(12):2344-2353. doi: 10.1136/gutjnl-2023-330155.
Garcia-Ortiz MV, Cano-Ramirez P, Toledano-Fonseca M, Aranda E, Rodriguez-Ariza A. Diagnosing and monitoring pancreatic cancer through cell-free DNA methylation: progress and prospects. Biomark Res. 2023 Oct 5;11(1):88. doi: 10.1186/s40364-023-00528-y.
plasma
Yinbin Liu, PhD
RenJi Hospital
First Submitted
May 8, 2025
First Posted
July 1, 2025
Study Start
October 30, 2022
Actual (reported)Primary Completion
January 22, 2026
Estimated (date passed)Indocyanine Green-Guided Versus Standard Laparoscopic Distal Pancreatectomy for Pancreatic Body and Tail Lesions
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 1, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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