Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreati… (NCT05737953) | Clinical Trial Compass
RecruitingNot Applicable
Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples
China100 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is collecting and analyzing cystic fluid samples from pancreatic cysts rather than testing a new treatment, would participating mean I need an extra procedure to collect that fluid, or would it use fluid that's already being taken out as part of my normal care?
2This trial is focused on building a diagnostic marker model using DNA methylation and protein analysis — could the results from my own cystic fluid sample potentially give us any useful information about my specific cyst, or is my sample only contributing to future research?
3Because this is listed as 'Phase NA,' it seems to be a research study rather than a treatment trial — how does this fit alongside whatever treatment plan you're already recommending for my pancreatic cyst, and would it delay or change anything about my care?
4The study is measuring cfDNA and proteins in pancreatic cystic fluid — are there any risks involved in having my cystic fluid collected or analyzed that I should weigh before deciding whether to participate?
5If this study eventually develops a better diagnostic tool for pancreatic cysts, would I or my family have any way to access those findings in the future, and is there anything I should know about how my sample and data will be stored or used?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Types and concentrations of cfDNA and proteins contained in the vesicular fluid