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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of Molecular Biology in Pancreatic Cyst Tumors

NCT03305146

Pancreatic Cyst Pancreas Cyst Serous Cystadenoma +2 more

ACTIVE_NOT_RECRUITING NA

Genomic Profiling of Pancreatic Cystic Tumors

NCT06195904

Pancreatic Cyst

NOT_YET_RECRUITING

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

NCT04835675

Hepatobiliary Malignancies

COMPLETED

Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer

NCT05208372

Stomach Neoplasms Metastasis

UNKNOWN

PaCIFiC-CUP Classifies Cancer of Unknown Primary

NCT06140992

Unknown Primary Tumors DNA Methylation

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neoplasms DNA Methylation Proteome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mucinous tumour group

cfDNA methylation sequencing and proteome analysis

Intervention Type DIAGNOSTIC_TEST

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

Non-mucinous tumour group

cfDNA methylation sequencing and proteome analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cfDNA methylation sequencing and proteome analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No