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NCT Number: NCT05737953

Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples

The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are:

Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from malignant and mucinous/non-mucinous, correlate with pathological features, and find molecular features associated with the degree of malignancy.

Participants will Provide post-operative cyst fluid specimens.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Kaixuan Wang, MD

CONTACT

[email protected]

86-21-31161353

About this study

Patients with pancreatic cystic tumors were divided into control, mucinous tumor and non-mucinous tumor groups, and cfDNA molecules and protein molecules that were significantly altered between different groups were found by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic detection techniques. Multi-omics analysis was performed to construct a more efficient molecular diagnostic marker model. Correlating models with pathological features to find molecular features associated with the degree of malignancy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects are ≥ 18 years old, regardless of gender;
  • Preoperative imaging examination (EUS, CT, MRI) diagnosed cystic mass of pancreas and suspected cystic tumor;
  • Subjects voluntarily accepted radical resection of pancreatic cystic tumors;
  • Subjects or family members voluntarily sign the informed consent form for clinical research.

Exclusion criteria

  • The excised sample does not contain cystic components, or the cystic fluid cannot be collected;
  • Receive tumor-related treatment (radiotherapy, chemotherapy, immunotherapy, etc.) before operation;
  • Receive antibiotic treatment within 1 week before operation;
  • Subjects refused to accept radical resection of pancreatic cystic tumor, or had any situation that they could not accept radical resection of pancreatic cystic tumor;
  • The subjects or their families refused to sign the informed consent form for clinical research.

Treatment and study plan

cfDNA methylation sequencing and proteome analysis

Diagnostic Test

Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples

Primary outcomes

  1. Types and concentrations of cfDNA and proteins contained in the vesicular fluid

    Time frame: 2023-11-31

    Identification of protein and circulating gene methylation species in cyst fluid and quantification of their concentrations using mass spectrometry. Characterize cfDNA methylation and proteomics of cyst fluid in patients with pancreatic cystic neoplasm (PCN).

Secondary outcomes

  1. Establishment of a diagnostic model for cystic tumors of the pancreas

    Time frame: 2023-11-31

    A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.Establishment of a diagnostic model for pancreatic cystic tumors.

  2. Establishing a model for the identification of mucus and non-mucus

    Time frame: 2023-11-31

    A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.To establish a model for the identification of mucinous and non-mucinous.

  3. Development of a progressive benign malignancy prediction model

    Time frame: 2023-11-31

    A machine learning approach was used to further screen for characteristically methylated cfDNA and proteins in PCN patients.Development of a progression benign malignancy prediction model.

Study contacts

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

Kaixuan Wang

CONTACT

[email protected]

021-31166666

Sponsors and collaborators

Lead sponsor

Zhaoshen Li

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Guangxi Medical University
  • First Hospital of China Medical University
  • LanZhou University
  • Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
  • Peking University Cancer Hospital & Institute
  • Shandong Province Third hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Baotou Medical College
  • West China Hospital
  • Zhejiang University

Registry information

Official study title

Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Feb 11, 2025

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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