Ki67 Proliferation Index Of Pancreatic Neuroendocrine Neoplasia

Study Overview

Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia

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.

N/A

Neuroendocrine Tumors

TNE P Ki-IPC 2020-046

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-02-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-16
First Submitted that Met QC Criteria 2021-02-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-18
First Posted (ACTUAL) 2021-02-15	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Ki67 Grade	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on pre-operative micro-biopsies
Ki67 Grade	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on surgical specimens

Secondary Outcome Measures	Measure Description	Time Frame
Percentage of Ki67 positive cells on total counted cells	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on surgical specimens
Percentage of Ki67 positive cells on total counted cells	Evaluation by digital pathology before and after machine learning	on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells	Evaluation by digital pathology before and after machine learning	on surgical specimens

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with resection of pancreatic neuroendocrine neoplasia by surgery at Paoli Calmettes Institute between January 2008 and June 2020
Patients who had a pre-surgical evaluation of Ki67 on micro-biopsy equipment obtained by echo-endoscopy.

Patient with a mixed tumor of the pancreas.
Patient with a pancreas tumor composed of several nodules of similar size without a main mass and for which it is not possible to determine the biopsied nodule during echo-endoscopy.
Initial micro-biopsy in a private pathology laboratory
Initial subechoendoscopic puncture cytology only (Ki67 not possible)
No initial micro-biopsy and surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Flora Poizat, Institut Paoli-Calmettes (IPC)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record