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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05737953
Enrollment
100
Registered
2023-02-21
Start date
2023-03-01
Completion date
2025-07-31
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Methylation, Pancreatic Neoplasms, Proteome

Keywords

Pancreas cystic neoplasm

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTcfDNA methylation sequencing and proteome analysis

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

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Types and concentrations of cfDNA and proteins contained in the vesicular fluid2023-11-31Identification 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

MeasureTime frameDescription
Establishment of a diagnostic model for cystic tumors of the pancreas2023-11-31A 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.
Establishing a model for the identification of mucus and non-mucus2023-11-31A 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.
Development of a progressive benign malignancy prediction model2023-11-31A 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.

Countries

China

Contacts

Primary ContactKaixuan Wang
lizfish@126.com021-31166666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026