The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer (MAP-02)

April 10, 2023 updated by: Peking Union Medical College Hospital

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:

  • prognostic value of baseline MRD;
  • the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

Study Locations

  • China
      • Beijing, China, 100032
        • Recruiting
        • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);
  • both sexes, age ≥18 years old;
  • ECOG performance status score ≤2;
  • the expected survival time was ≥3 months.

Exclusion Criteria:

  • a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
  • treated with any systemic antitumor treatment before first-line chemotherapy onset;
  • died or lost to follow-up within one month after the initiation of adjuvant chemotherpay;
  • combined with other primary malignances.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRD-guided
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.
Drug: Later-line therapy
Another chemotherapy regimen, targeted therapy, or immunotherapy
No Intervention: Routine treatment
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: Baseline until death from any cause (up to approximately 36 months)
The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.
Baseline until death from any cause (up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Baseline until death from any cause (up to approximately 60 months)
The date of adjuvant chemotherpay initiation to death due to any cause.
Baseline until death from any cause (up to approximately 60 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prognostic value of MRD
Time Frame: Baseline until death from any cause (up to approximately 60 months)
The prognostic value of baseline MRD and dynamic MRD changes
Baseline until death from any cause (up to approximately 60 months)
The prognostic role of targeted therapy selected based on MRD
Time Frame: Baseline until death from any cause (up to approximately 60 months)
The prognostic role of targeted therapy selected based on MRD
Baseline until death from any cause (up to approximately 60 months)

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Chunmei Bai, MD, Peking Union Medical College Hospital

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 (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2026

Study Completion (Anticipated)

February 1, 2030

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K3378-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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