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NCT05479708Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
28 Jul 2022
Start date
9 Aug 2023
Primary completion date
Jan 2028
Lead sponsor
BAIYONG SHEN
NCT number
NCT05479708

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 9 Aug 2023 to the primary completion date, Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving neo-adjuvant therapy before surgery
  • Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
  • Prior transplantation of bone marrow, stem cell or organ

Other illness

  • With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders
  • Distant organ metastasis or malignant ascites

Other

  • Pregnant or breastfeeding at time of enrollment

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.