ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

NCT05479708 | Active Not Recruiting

• 1 other identifier: D-P220426-MRD-RJ-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Resectable

Keywords

circulating tumor DNA; minimal residual disease

Outcome Measures

Primary Outcomes (1)

• Death and overall survival

  Overall survival difference between MRD-positive and MRD-negative patients

  3 years

Interventions

ctDNA-based MRD detection DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The pathologically diagnosed stage I-III PAAD patients who underwent resections carried KRAS mutations in 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GeneCast Biotechnology Co., Ltd.: collaborator
• BAIYONG SHEN: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Matched tumor tissues, plasma samples and blood cells

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baiyong Shen, Ph.D

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: August 9, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)