Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors
Recruiting · NCT05847855 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
Blood collection
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Fudan University shanghai cancer center - Shanghai, Shanghai Municipality, China
- West China Hospital, Sichuan University - Chengdu, Sichuan, China