Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia

Comparison of the Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia Between Preoperative Micro-biopsies and Surgical Specimens

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04753229

Acronym

TNE-P-Ki

Enrollment

Registered

2021-02-15

Start date

2008-01-01

Completion date

2020-10-01

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

pancreatic neuroendocrine tumor, Ki67, artificial intelligency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Ki67 Grade	on pre-operative micro-biopsies	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

Secondary

Measure	Time frame	Description
Percentage of Ki67 positive cells on total counted cells	on preoperative micro-biopsies	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

Outcome results