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

February 17, 2023 updated by: Zhaoshen Li

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

Intervention / Treatment

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 (Anticipated)

100

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
    • Shanghai
      • Shanghai, Shanghai, China, 200433

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

Genders Eligible for Study

All

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

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

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
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).
2023-11-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2023-11-31
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.
2023-11-31
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.
2023-11-31

Collaborators and Investigators

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

Sponsor

Zhaoshen Li

Investigators

  • Principal Investigator: Shiyu Li, Changhai hospital
  • Study Chair: Chengye Pan, Changhai 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)

July 13, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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