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

NCT05737953 | Recruiting

• 1 other identifier: WKX2023-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; DNA Methylation; Proteome

Keywords

Pancreas cystic neoplasm

Outcome Measures

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).

  2023-11-31

Secondary Outcomes (3)

• Establishment of a diagnostic model for cystic tumors of the pancreas

  2023-11-31

• Establishing a model for the identification of mucus and non-mucus

  2023-11-31

• Development of a progressive benign malignancy prediction model

  2023-11-31

Study Arms (2)

Mucinous tumour group

Diagnostic Test: cfDNA methylation sequencing and proteome analysis

Non-mucinous tumour group

Diagnostic Test: cfDNA methylation sequencing and proteome analysis

Interventions

cfDNA methylation sequencing and proteome analysis DIAGNOSTIC_TEST

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

Mucinous tumour group; Non-mucinous tumour group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cystic tumor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University: collaborator
• Zhaoshen Li: lead
• 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

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cystic fluid in pancreatic cystic tumour

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Shiyu Li

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Chengye Pan

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Kaixuan Wang

CONTACT

021-31166666; lizfish@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastroenterology Department of Changhai Hospital

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CN (1)