Clinical trial NCT05737953: Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasms
DNA Methylation
Proteome
Keywords: Pancreas cystic neoplasm
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
name: Zhejiang University
name: The First Affiliated Hospital of Nanchang University
name: West China Hospital
name: LanZhou University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Peking University Cancer Hospital & Institute
name: First Hospital of China Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Second Affiliated Hospital of Baotou Medical College
name: Shandong Province Third hospital
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cystic tumor

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.

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.

Primary outcomes:
measure: Types and concentrations of cfDNA and proteins contained in the vesicular fluid
timeFrame: 2023-11-31
Secondary outcomes:
measure: Establishment of a diagnostic model for cystic tumors of the pancreas
timeFrame: 2023-11-31
measure: Establishing a model for the identification of mucus and non-mucus
timeFrame: 2023-11-31
measure: Development of a progressive benign malignancy prediction model
timeFrame: 2023-11-31
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Shiyu Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Chengye Pan
role: STUDY_CHAIR
References: