Construction Of Molecular Diagnostic Marker Model For Pancreatic Cystic Tumors Based On Pancreatic Cystic Fluid Samples

Study Overview

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.

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.

Pancreatic Neoplasms
DNA Methylation
Proteome

DIAGNOSTIC_TEST: cfDNA methylation sequencing and proteome analysis

WKX2023-02

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-07
First Submitted that Met QC Criteria 2023-02-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-11
First Posted (ACTUAL) 2023-02-21	Results First Posted N/A	Last Verified 2025-02

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Mucinous tumour group	DIAGNOSTIC_TEST: cfDNA methylation sequencing and proteome analysis Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples
: Non-mucinous tumour group	DIAGNOSTIC_TEST: cfDNA methylation sequencing and proteome analysis Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples

Participant Group/Arm

Intervention/Treatment

: Mucinous tumour group

DIAGNOSTIC_TEST: cfDNA methylation sequencing and proteome analysis

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

: Non-mucinous tumour group

DIAGNOSTIC_TEST: cfDNA methylation sequencing and proteome analysis

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

Primary Outcome Measures	Measure Description	Time Frame
Types and concentrations of cfDNA and proteins contained in the vesicular fluid	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).	2023-11-31

Secondary Outcome Measures	Measure Description	Time Frame
Establishment of a diagnostic model for cystic tumors of the pancreas	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.	2023-11-31
Establishing a model for the identification of mucus and non-mucus	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.	2023-11-31
Development of a progressive benign malignancy prediction model	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.	2023-11-31

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: Kaixuan Wang

Phone Number: 021-31166666

Email: lizfish@126.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

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

Investigators

PRINCIPAL_INVESTIGATOR: Shiyu Li, Changhai Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record