Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406387
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-06
Brief Title:
ATRXDAXX in EUS-FNB Specimens of Pan-NETs
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Association Between Endoscopic Ultrasound Based Preoperative ATRXDAXX Immunohistochemistry Expression and Prognosis of Sporadic Non-FunctiOnal pancREatic Neuroendocrine tumorS a prospEctivE Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORESEE
Brief Summary:
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 andor in α-thalassemiamental retardation X-linked ATRX chromatin remodeling genes are associated with more aggressive disease In a retrospective study the investigators recently evaluated the correspondence of DAXXATRX expression on 41 EUS-FNB samples with corresponding surgical specimens demonstrating a 951 almost perfect agreement κ 0828 p 0001 and 927 substantial agreement κ 0626 p 0001 concordance for DAXX and ATRX expression respectively This study aims to evaluate the potential clinicalprognostic role of DAXXATRX expression as implementation of the currently used Ki67-based grading evaluated on EUS-FNB samples in a prospective cohort of patients with NF-pNETs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None