Clinical trial · Observational
Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors
A Prospective Study of Plasma Cell-free DNA Fragmentomics for Early Detection of Pancreatic Neuroendocrine Tumors and Differential Diagnosis of Solid Pancreatic Tumors
NCT05847855CI-TRIAL-00106386recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
| Solid Pancreatic Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- pNETs
- description
- Patients with pancreatic neuroendocrine tumors (pNETs). The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed.
- interventionNames
- Diagnostic Test: Blood collection
- label
- Healthy
- description
- Healthy volunteers. The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed.
- interventionNames
- Diagnostic Test: Blood collection
- label
- PDAC
- description
- Patients with pancreatic ductal adenocarcinoma (PDAC) . The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDFischer L, Bergmann F, Schimmack S, Hinz U, Priess S, Muller-Stich BP, Werner J, Hackert T, Buchler MW. Outcome of surgery for pancreatic neuroendocrine neoplasms. Br J Surg. 2014 Oct;101(11):1405-12. doi: 10.1002/bjs.9603. Epub 2014 Aug 13. PMID 25132004
- BACKGROUNDDasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID 28448665
- BACKGROUNDZhang X, Wang Z, Tang W, Wang X, Liu R, Bao H, Chen X, Wei Y, Wu S, Bao H, Wu X, Shao Y, Fan J, Zhou J. Ultrasensitive and affordable assay for early detection of primary liver cancer using plasma cell-free DNA fragmentomics. Hepatology. 2022 Aug;76(2):317-329. doi: 10.1002/hep.32308. Epub 2022 Jan 26. PMID 34954829
- BACKGROUNDFece de la Cruz F, Corcoran RB. Methylation in cell-free DNA for early cancer detection. Ann Oncol. 2018 Jun 1;29(6):1351-1353. doi: 10.1093/annonc/mdy134. No abstract available. PMID 29668834
- BACKGROUNDMathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w. PMID 34417454
- BACKGROUNDSnyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.