CtDNA-based Minimal Residual Disease Detection For Resected Pancreatic Adenocarcinoma

Study Overview

ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

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.

N/A

Pancreatic Cancer Resectable

DEVICE: ctDNA-based MRD detection

D-P220426-MRD-RJ-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-07-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-21
First Submitted that Met QC Criteria 2022-07-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-24
First Posted (ACTUAL) 2022-07-29	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Death and overall survival	Overall survival difference between MRD-positive and MRD-negative patients	3 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

GeneCast Biotechnology Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Baiyong Shen, Ph.D, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record