ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

Pancreatic Cancer Resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05479708
• Other study ID #: D-P220426-MRD-RJ-1
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: November 2025

Study information

• Verified date: July 2022
• Source: Ruijin Hospital
• Contact: Qian Zhan, MD
• Phone: +86-021-64370045
• Email: zhanxi80[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasm, Residual
• Pancreatic Cancer Resectable

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
BAIYONG SHEN	GeneCast Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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