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Trial Title:
Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
NCT ID:
NCT05737953
Condition:
Pancreatic Neoplasms
DNA Methylation
Proteome
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreas cystic neoplasm
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cfDNA methylation sequencing and proteome analysis
Description:
Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid
samples
Arm group label:
Mucinous tumour group
Arm group label:
Non-mucinous tumour group
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.
Criteria for eligibility:
Study pop:
Patients with pancreatic cystic tumor
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaixuan Wang, MD
Phone:
86-21-31161353
Email:
wangkaixuan224007@sina.com
Start date:
July 13, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Zhaoshen Li
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737953
