Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753229
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2021-02-09
Brief Title:
Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia
Sponsor:
Institut Paoli-Calmettes
Organization:
Institut Paoli-Calmettes
Study Overview
Official Title:
Comparison of the Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia Between Preoperative Micro-biopsies and Surgical Specimens
Status:
COMPLETED
Status Verified Date:
2021-02
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:
TNE-P-Ki
Brief Summary:
This is a retrospective monocentric study involving 50 patients with pancreatic neuroendocrine neoplasia resected between January 2008 and June 2020 at Paoli Calmettes Institute
The primary objective of the study is to evaluate the grade concordance rate based on Ki67 obtained on the pre-operative micro-biopsy and the surgical specimen
Based on the histology slides obtained in the course of the treatment several Ki67 recounts will be performed on pre-operative tumor micro-biopsies and on tumors resected after surgery
a manual count on photo printed in the hotspot area according to World Health Organization WHO 2017 recommendations by an expert pathologist and a junior pathologist
Automated counting using specific software based on artificial intelligence Qpath software
On the other hand clinical surgical and anatomopathological data will be collected in order to follow the patient evolution
The primary objective of the study is to evaluate the grade concordance rate based on Ki67 obtained on the pre-operative micro-biopsy and the surgical specimen
Based on the histology slides obtained in the course of the treatment several Ki67 recounts will be performed on pre-operative tumor micro-biopsies and on tumors resected after surgery
a manual count on photo printed in the hotspot area according to World Health Organization WHO 2017 recommendations by an expert pathologist and a junior pathologist
Automated counting using specific software based on artificial intelligence Qpath software
On the other hand clinical surgical and anatomopathological data will be collected in order to follow the patient evolution
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