Blood collection: Blood collection for fragmentomic profiles of plasma cell-free DNA. The sub-center shall use the same blood collection consumables (EDTA anticoagulant vacutainer tubes) and blood collection volume (10ml) as the main center; plasma separation shall be completed within 2 hours after blood collection, and all operations shall comply with the study's unified SOP.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs — From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years. Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Sensitivity and specificity of the model for differential diagnosis among solid pancreatic tumors — From first blood draw until histopathological diagnosis, up to 3 years Sensitivity and specificity of the model for differential diagnosis among PDAC, pNET and SPT.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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