Viewing Study NCT06343428



Ignite Creation Date: 2024-05-06 @ 8:20 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06343428
Status: RECRUITING
Last Update Posted: 2024-05-06
First Post: 2024-03-18

Brief Title: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients
Sponsor: European Institute of Oncology
Organization: European Institute of Oncology

Study Overview

Official Title: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients an observAtional Prospective Analysis of the Correlation Between Functional Imaging and Clinical Outcome TAPIOCA
Status: RECRUITING
Status Verified Date: 2024-03
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: TAPIOCA
Brief Summary: The 2017 World Health Organization WHO introduced a new category of high-grade well-differentiated neuroendocrine neoplasms NENs that called neuroendocrine tumors NETs G3 in pancreatic NENs classification and then in 2019 for all gastro-entero-pancreatic GEP tract NENs

The new classification made it possible to separate NETs G3 from high-grade poorly-differentiated NENs that are called neuroendocrine carcinomas NECs

However in clinical practice we observed that several clinical pathological and radiological differences are arising among NET G3 patients suggesting that a multiparametric definition of NET G3 is needed
Detailed Description: High-grade neuroendocrine neoplasms NENs represent the poorest prognosis category within NENs During the years the prognostic differences among the subgroups led to identify at least two subcategories of high-grade NENs according the morphologic features of the two subtypes

Indeed the 2017 World Health Organization WHO introduced a new category of high-grade well-differentiated NENs that called neuroendocrine tumors NETs G3 for pancreatic NENs and then in 2019 for all gastro-entero-pancreatic GEP tract NENs allowing to separate NET G3 from the other high-grade poorly-differentiated NENs so called neuroendocrine carcinomas NECs

However since the new-category has been introduced NET G3 category seemed to be more heterogeneous than presumed Indeed clinical pathological and radiological features seemed to identify different prognostic subcategories of NET G3 We recently performed a retrospective analysis on a small pool of 48 NET G3 patients correlating the clinical outcomes with these different features The results of our study seemed to suggest prognostic and predictive factors that deserve to be prospectively explored to better understand this pathology and that might to be part of NET G3 multiparametric classification system Based on the results of our retrospective analysis we underlined the importance of a systematic and well-designed collection of high-quality data in order to improve our knowledge on this topic

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