Actively Recruiting
Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
Led by Zhaoshen Li · Updated on 2025-02-11
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zhaoshen Li
Lead Sponsor
O
Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study patients with pancreatic cystic tumors to identify molecular diagnostic markers. It evaluates how cfDNA methylation sequencing and proteomic analysis of pancreatic cystic fluid can help distinguish between benign and malignant tumors, as well as mucinous and non-mucinous types. The study also seeks to correlate these molecular findings with pathological features and determine markers linked to the tumor's degree of malignancy. Participants will provide samples of cystic fluid obtained after surgery. The study groups include mucinous tumor and non-mucinous tumor groups. Researchers will analyze cfDNA molecules and proteins in these fluid samples using sequencing and proteomic techniques. Multi-omics analysis will be performed to build a molecular diagnostic marker model to better identify and classify pancreatic cystic tumors. During the study, participants will undergo post-operative collection of cyst fluid specimens. Researchers will measure the types and concentrations of cfDNA and proteins in the fluid. They will also establish diagnostic models for pancreatic cystic tumors to differentiate mucinous from non-mucinous types and predict the progression from benign to malignant tumors. The study is observational and monitors molecular markers without administering treatments.
CONDITIONS
Brief Title
Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are 18 years old or older, any gender
- Diagnosed with pancreatic cystic mass by imaging (EUS, CT, MRI) and suspected cystic tumor
- Voluntarily accepted surgical removal of pancreatic cystic tumor
- Signed informed consent form for clinical research by subject or family
You will not qualify if you...
- Excised sample lacks cystic components or cystic fluid cannot be collected
- Received tumor-related treatment (radiotherapy, chemotherapy, immunotherapy) before surgery
- Received antibiotic treatment within 1 week before surgery
- Refused or unable to accept surgical removal of pancreatic cystic tumor
- Subject or family refused to sign informed consent form for clinical research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants provide pancreatic cystic fluid samples which are analyzed using cfDNA methylation sequencing and proteomic techniques to identify molecular markers associated with pancreatic cystic tumors.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed to correlate molecular diagnostic models with pathological features and malignancy progression.
Follow-up visits as needed based on clinical care
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
K
Kaixuan Wang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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