Developing a diagnostic model for pancreatic cystic tumors using fluid samples
Official title: Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
Run by Changhai Hospital · NCT05737953 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT05737953 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies exploring molecular markers in pancreatic tumors, this specific approach using cfDNA methylation and proteomics is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Changhai Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Shiyu Li — Changhai Hospital
- Study coordinator: Kaixuan Wang
- Email: lizfish@126.com
- Phone: 021-31166666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.