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NCT Number: NCT05479708

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Resectable Neoplasm, Residual Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ctDNA-based MRD detection

Device

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

Primary outcomes

  1. Death and overall survival

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

BAIYONG SHEN

Other

Collaborators

  • GeneCast Biotechnology Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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