Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia

NCT04753229 | Completed

• 1 other identifier: TNE P Ki-IPC 2020-046
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroendocrine Tumors

Keywords

pancreatic neuroendocrine tumor; Ki67; artificial intelligency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Percentage of Ki67 positive cells on total counted cells

  on preoperative micro-biopsies

• Percentage of Ki67 positive cells on total counted cells

  on surgical specimens

• Percentage of Ki67 positive cells on total counted cells

  on preoperative micro-biopsies

• Percentage of Ki67 positive cells on total counted cells

  on surgical specimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Conditions

Neuroendocrine Tumors; Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenoma; Neoplasms, Glandular and Epithelial; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Flora Poizat

  Institut Paoli-Calmettes (IPC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: January 1, 2008
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02