Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cfDNA methylation sequencing and proteome analysis.
- Who it may be relevant to
- Registry conditions: Pancreatic Neoplasms, DNA Methylation, Proteome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
Overview
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 test cfDNA methylation sequencing and proteome analysis
Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples
Primary outcome measures
- Types and concentrations of cfDNA and proteins contained in the vesicular fluid [Time frame: 2023-11-31]
Secondary outcome measures (3)
- Establishment of a diagnostic model for cystic tumors of the pancreas [Time frame: 2023-11-31]
- Establishing a model for the identification of mucus and non-mucus [Time frame: 2023-11-31]
- Development of a progressive benign malignancy prediction model [Time frame: 2023-11-31]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Changhai Hospital — Shanghai
Identifiers
NCT: NCT05737953 · WKX2023-02