NCT06406387Active, not recruiting
ATRX/DAXX in EUS-FNB Specimens of Pan-NETs
Association Between Endoscopic Ultrasound Based Preoperative ATRX/DAXX Immunohistochemistry Expression and Prognosis of Sporadic, Non-FunctiOnal pancREatic Neuroendocrine tumorS: a prospEctivE Cohort Study
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
P-NENs are classified as functional (F-) or non-functional (NF-) depending on the presence or absence of a clinical hormonal hypersecretion syndrome. Moreover, the WHO 2017 classification of pNENs distinguishes between well-differentiated pancreatic neuroendocrine tumors (pNETs) and poorly differentiated pancreatic neuroendocrine carcinomas (pNECs). pNETs are then divided according to a grading scheme based on Ki67 index in pNETs-G1 (Ki67 index ≤3%) and pNETs-G2 (Ki67 index between 4% and 20%). pNECs are all G3, with a Ki67 index \>20%. Endoscopic ultrasound with fine-needle biopsy (EUS-FNB) demonstrated safe and effective preoperative grading based on the Ki-67 proliferative index. However, downstaging rate is not neglectable, reaching 15% in a recent metanalysis. Moreover, recent whole-exome and whole genome sequencing studies revealed that the mutually exclusive inactivating mutations in death domain-associated protein (DAXX) and/or in α-thalassemia/mental retardation X-linked (ATRX) chromatin remodeling genes are associated with more aggressive disease. In a retrospective study, the investigators recently evaluated the correspondence of DAXX/ATRX expression on 41 EUS-FNB samples with corresponding surgical specimens demonstrating a 95.1% (almost perfect agreement, κ = 0.828; p \< 0.001) and 92.7% (substantial agreement, κ = 0.626; p \< 0.001) concordance for DAXX and ATRX expression, respectively. This study aims to evaluate the potential clinical/prognostic role of DAXX/ATRX expression as implementation of the currently used Ki67-based grading, evaluated on EUS-FNB samples in a prospective cohort of patients with NF-pNETs
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 6 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT06406387
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 Jun 2024 to the primary completion date, 30 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
- Failure to sign the patient's or closest relative's informed consent
Lab values
- INR \>1.5 or platelet count \<50.000
Other
- Functional pNETs
- Multiple pancreatic nodules
- Diagnosis of MEN-1 or Von-Hippel Lindau
- Mixed types (e.g., mixed neuroendocrine-acinar/adenocarcinoma) or neuroendocrine carcinomas
- Predominantly cystic lesions (more than 50% of the volume).
- Metastatic tumors at the time of diagnosis
- Use of anticoagulants that cannot be discontinued
- Pregnancy or breastfeeding
Who the study is looking for
- Age ≥18 years
- Cyto/histologic diagnosis of pNETs
- Signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.