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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; DNA Methylation; Proteome
• Intervention / Treatment: Diagnostic test: cfDNA methylation sequencing and proteome analysis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Kaixuan Wang; Phone Number: 021-31166666; Email: lizfish@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Kaixuan Wang, MD; Phone Number: 86-21-31161353; Email: wangkaixuan224007@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cystic tumor

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Zhaoshen Li
• Collaborators: The First Affiliated Hospital of Nanchang University; LanZhou University; West China Hospital; Peking University Cancer Hospital & Institute; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Zhejiang University; First Hospital of China Medical University; First Affiliated Hospital of Guangxi Medical University; The Second Affiliated Hospital of Baotou Medical College; Shandong Province Third hospital; Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
• Investigators: Principal Investigator: Shiyu Li, Changhai Hospital; Study Chair: Chengye Pan, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pancreas cystic neoplasm
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: WKX2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: cfDNA methylation data and proteome analysis data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No