ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

July 29, 2022 updated by: BAIYONG SHEN

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

  • Name: Qian Zhan, MD
  • Phone Number: 670903 +86-021-64370045
  • Email: zhanxi80@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

BAIYONG SHEN

Collaborators

GeneCast Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Baiyong Shen, Ph.D, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

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 Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-P220426-MRD-RJ-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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