Clinical trial · Observational
Optimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation
Optimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation: a Retrospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are heterogeneous neoplasms of the pancreatic endocrine tissue, displaying variable clinical behavior from indolent to highly aggressive forms. Their often asymptomatic nature and lack of reliable preoperative biomarkers make clinical management particularly challenging. This exploratory study will investigate cell-free DNA (cfDNA) as a potential non-invasive biomarker in NF-PanNETs. cfDNA samples from approximately 30 patients, representing distinct clinical courses (active surveillance, indolent post-surgical, and aggressive post-surgical cases), will be analyzed using advanced methylome and nucleosome footprinting techniques. The aim is to evaluate cfDNA's diagnostic and prognostic potential to improve disease monitoring and support personalized therapeutic strategies in NF-PanNET patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA molecular profiling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- histological indolent PanNET
- description
- patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of indolent disease
- interventionNames
- Other: cfDNA molecular profiling
- label
- histological aggressive PanNET
- description
- patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of aggressive disease
- interventionNames
- Other: cfDNA molecular profiling
- label
- PanNET under active surveillance
- description
- patients currently under active surveillance for small indolent pancreatic neuroendocrine tumor (PanNET)
- interventionNames
- Other: cfDNA molecular profiling
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Diagnosis of sporadic, well-differentiated, non-functioning pancreatic neuroendocrine tumor (NF-PanNET). * Signed informed consent for the use of plasma samples stored in the "NETbank" biobank. * Availability of pre-operative or surveillance plasma samples. Exclusion Criteria: * Genetic syndromes associated with NF-PanNETs (e.g., MEN1, VHL). * Functioning PanNETs. * Inadequate quality or quantity of circulating-free DNA (cfDNA) extracted from plasma samples.
References
Publications (8)
- BACKGROUNDLoyfer N, Magenheim J, Peretz A, Cann G, Bredno J, Klochendler A, Fox-Fisher I, Shabi-Porat S, Hecht M, Pelet T, Moss J, Drawshy Z, Amini H, Moradi P, Nagaraju S, Bauman D, Shveiky D, Porat S, Dior U, Rivkin G, Or O, Hirshoren N, Carmon E, Pikarsky A, Khalaileh A, Zamir G, Grinbaum R, Abu Gazala M, Mizrahi I, Shussman N, Korach A, Wald O, Izhar U, Erez E, Yutkin V, Samet Y, Rotnemer Golinkin D, Spalding KL, Druid H, Arner P, Shapiro AMJ, Grompe M, Aravanis A, Venn O, Jamshidi A, Shemer R, Dor Y, Glaser B, Kaplan T. A DNA methylation atlas of normal human cell types. Nature. 2023 Jan;613(7943):355-364. doi: 10.1038/s41586-022-05580-6. Epub 2023 Jan 4. PMID 36599988
- BACKGROUNDVaisvila R, Ponnaluri VKC, Sun Z, Langhorst BW, Saleh L, Guan S, Dai N, Campbell MA, Sexton BS, Marks K, Samaranayake M, Samuelson JC, Church HE, Tamanaha E, Correa IR Jr, Pradhan S, Dimalanta ET, Evans TC Jr, Williams L, Davis TB. Enzymatic methyl sequencing detects DNA methylation at single-base resolution from picograms of DNA. Genome Res. 2021 Jul;31(7):1280-1289. doi: 10.1101/gr.266551.120. Epub 2021 Jun 17. PMID 34140313
- BACKGROUNDCowzer D, Shah RH, Chou JF, Kundra R, Punn S, Fiedler L, DeMore A, Capanu M, Berger MF, Reidy-Lagunes D, Raj N. Clinical utility of plasma cell-free DNA in pancreatic neuroendocrine neoplasms. Endocr Relat Cancer. 2024 Mar 4;31(4):e230292. doi: 10.1530/ERC-23-0292. Print 2024 Apr 1. PMID 38252063
- BACKGROUNDOversoe SK, Sorensen BS, Tabaksblat EM, Gronbaek H, Kelsen J. Cell-Free DNA and Clinical Characteristics in Patients with Small Intestinal or Pancreatic Neuroendocrine Tumors. Neuroendocrinology. 2022;112(1):43-50. doi: 10.1159/000514457. Epub 2021 Jan 18. PMID 33461190
- BACKGROUNDBoons G, Vandamme T, Peeters M, Beyens M, Driessen A, Janssens K, Zwaenepoel K, Roeyen G, Van Camp G, Op de Beeck K. Cell-Free DNA From Metastatic Pancreatic Neuroendocrine Tumor Patients Contains Tumor-Specific Mutations and Copy Number Variations. Front Oncol. 2018 Nov 1;8:467. doi: 10.3389/fonc.2018.00467. eCollection 2018. PMID 30443491