RecruitingNot Applicable

Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors

China1,000 participantsStarted 2023-02-27

Plain-language summary

This prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA for early detection of pancreatic neuroendocrine tumors and differential diagnosis of solid pancreatic tumors.

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: * Age 18 and above, regardless of gender; * Histopathological diagnosis with non-functional pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor; * Not receiving any anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy; * No obvious surgical contraindications; * Able to comply with research plans, follow-up plans, and other protocol requirements; * Voluntary participation and signed informed consent. Exclusion Criteria: * Pathological diagnosis was not pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor; * Currently diagnosed with other types of tumors or any cancer history; * Diagnosed with familial syndromes; * Receiving anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy; * Ongoing fever or recipient of anti-inflammation therapy within 14 days prior to study blood draw; * Recipient of blood transfusion within 30 days prior to study blood draw; * Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant; * Poor health condition and not suitable for blood draw; * Any other disease/condition deemed not suitable for study enrollment by researcher.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs

Timeframe: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years.

Sensitivity and specificity of the model for differential diagnosis among solid pancreatic tumors

Timeframe: From first blood draw until histopathological diagnosis, up to 3 years

Trial details

NCT IDNCT05847855

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Xianjun Yu, MD, PhD

021-64175590-88503 yuxianjun@fudanpci.org

View on ClinicalTrials.gov More Pancreatic Neuroendocrine Tumor trials