Developing a diagnostic model for pancreatic cystic tumors using fluid samples

Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples

This study is testing if analyzing fluid samples from patients with pancreatic cystic tumors can help doctors tell the difference between harmless and harmful tumors.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05737953 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify molecular diagnostic markers for pancreatic cystic tumors by analyzing cystic fluid samples from patients. It involves cfDNA methylation sequencing and proteomic assays to differentiate between benign and malignant tumors, as well as mucinous and non-mucinous types. Participants will provide post-operative cyst fluid specimens, which will be analyzed to correlate molecular features with pathological characteristics and malignancy levels. The study seeks to construct a more effective diagnostic model through multi-omics analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a preoperative diagnosis of pancreatic cystic tumors who are willing to undergo radical resection.

Not a fit: Patients who have received prior tumor-related treatments or whose excised samples do not contain cystic components may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy for pancreatic cystic tumors, enabling better treatment decisions.

How similar studies have performed: While there have been studies exploring molecular markers in pancreatic tumors, this specific approach using cfDNA methylation and proteomics is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Shiyu Li — Changhai Hospital
• Study coordinator: Kaixuan Wang

Conditions: Pancreatic Neoplasms, DNA Methylation, Proteome, Pancreas cystic neoplasm