ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

Postoperative ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma: A Prospective Observational Cohort Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05479708

Enrollment

150

Registered

2022-07-29

Start date

2023-08-09

Completion date

2028-08-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer Resectable

Keywords

circulating tumor DNA, minimal residual disease

Brief 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.

Interventions

DEVICEctDNA-based MRD detection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
Death and overall survival	3 years	Overall survival difference between MRD-positive and MRD-negative patients

Countries

China

Contacts

PRINCIPAL_INVESTIGATORBaiyong Shen, Ph.D

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026