Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
The study population enrolled by the main center and the sub-center is uniformly divided into four groups with the same enrollment criteria for all. 1. pNET Group: Not receiving anti-tumor treatment before surgery, and were histopathologically confirmed pancreatic neuroendocrine tumors. 2. PDAC group: Patients with histopathologically confirmed pancreatic ductal adenocarcinoma (PDAC) who have not received any anti-tumor treatment before surgery. 3. SPT group: Patients with histopathologically confirmed solid pseudopapillary tumor (SPT) of the pancreas who have not received any anti-tumor treatment before surgery. 4. Healthy group: Healthy volunteers without a history of tumors and no pancreatic organic diseases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood collection
Diagnostic testBlood 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.
Treatment groups
1,000 Participants
are divided into 4 treatment groupsGroup A: pNETs1 intervention
Group B: Healthy1 intervention
Group C: PDAC1 intervention
Group D: SPT1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs
Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Time frame
From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years.2
Sensitivity and specificity of the model for differential diagnosis among solid pancreatic tumors
Sensitivity and specificity of the model for differential diagnosis among PDAC, pNET and SPT.
Time frame
From first blood draw until histopathological diagnosis, up to 3 yearsSecondary outcomes
1
Positive predictive value and negative predictive value
Positive predictive value (PPV) and negative predictive value (NPV) of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Time frame
From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years2
Accuracy of the model in predicting AJCC stage (where applicable) and tumor grade
Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA in predicting AJCC stage (where applicable) and tumor grade
Time frame
From date of first blood draw until first documented histopathological diagnosis, assessed up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
West China Hospital
Collaborator
Source ClinicalTrials.gov