Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhaoshen Li
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Patients with pancreatic cystic tumor
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
cfDNA methylation sequencing and proteome analysis
Diagnostic testSequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mucinous tumour group1 intervention
Group B: Non-mucinous tumour group1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2023-11-31Secondary outcomes
1
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.
Time frame
2023-11-312
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.
Time frame
2023-11-313
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.
Time frame
2023-11-31Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhaoshen Li
Lead sponsor
Changhai Hospital
Sponsor institution
Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Collaborator
Zhejiang University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
West China Hospital
Collaborator
LanZhou University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
First Hospital of China Medical University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The Second Affiliated Hospital of Baotou Medical College
Collaborator
Shandong Province Third hospital
Collaborator
Source ClinicalTrials.gov