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NCT Number: NCT05802407

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

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.

Recruiting

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Resectable Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100032, China

Location status: Recruiting

Location contact

Chunmei Bai, M.D.

CONTACT

[email protected]

010-69168764

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Later-line therapy

Drug

Another chemotherapy regimen, targeted therapy, or immunotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunmei Bai, MD

CONTACT

[email protected]

010-69158764 ext. +86

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Acronym: MAP-02

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Apr 6, 2023
Registry last updated
Apr 12, 2023

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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