Examining ATRX and DAXX in pancreatic neuroendocrine tumors
Association Between Endoscopic Ultrasound Based Preoperative ATRX/DAXX Immunohistochemistry Expression and Prognosis of Sporadic, Non-FunctiOnal PancREatic Neuroendocrine TumorS: a ProspEctivE Cohort Study
This study is trying to see if certain gene changes in pancreatic neuroendocrine tumors can help doctors better understand how aggressive the tumors are and improve treatment options for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 1 site (Verona) |
| Trial ID | NCT06406387 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pancreatic neuroendocrine tumors (pNETs) and aims to evaluate the presence of ATRX and DAXX mutations in specimens obtained through endoscopic ultrasound with fine-needle biopsy (EUS-FNB). The study will classify pNETs based on their functional status and grading according to the Ki-67 index, which is crucial for determining the tumor's aggressiveness. By analyzing these mutations, the study seeks to improve preoperative grading and understanding of pNETs. The findings could help refine treatment strategies for patients with these tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of pancreatic neuroendocrine tumors.
Not a fit: Patients with functional pancreatic neuroendocrine tumors, multiple pancreatic nodules, or those with certain genetic syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate preoperative grading of pancreatic neuroendocrine tumors, potentially improving patient outcomes.
How similar studies have performed: While this study explores the role of ATRX and DAXX mutations in pNETs, similar approaches have shown promise in other tumor types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Cyto/histologic diagnosis of pNETs * Signed informed consent Exclusion Criteria: * 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 * Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma * Use of anticoagulants that cannot be discontinued * INR \>1.5 or platelet count \<50.000 * Pregnancy or breastfeeding * Failure to sign the patient's or closest relative's informed consent
Where this trial is running
Verona
- University Hospital of Verona — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Francesco Crinò, MD, PhD
- Email: stefanofrancesco.crino@aovr.veneto.it
- Phone: 00390458126191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.