ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

NCT05479708 · tracked via the Priya Life Science China tracker

Sponsor

BAIYONG SHEN

Phase

Observational

Started

2023-08-09

Last updated

2026-04-08

Condition(s) studied

Pancreatic Cancer Resectable

Investigational drug(s) / intervention(s)

ctDNA-based MRD detection

ctDNA-based MRD detection: Postoperative circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) detection for predicting relapse and survival benefit

Study summary

Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Pathologically diagnosed pancreatic adenocarcinoma (stage I-III) * KRAS mutations identified in resected tumor tissues * Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) * Receiving adjuvant chemotherapy * ECOG 0-2 * Signed informed consent Exclusion Criteria: * With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders * Distant organ metastasis or malignant ascites * Receiving neo-adjuvant therapy before surgery * Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy) * Pregnant or breastfeeding at time of enrollment * Prior transplantation of bone marrow, stem cell or organ

Primary outcome measure(s)

Death and overall survival — 3 years
Overall survival difference between MRD-positive and MRD-negative patients

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05479708 on ClinicalTrials.gov ↗ ← All trials in China