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NCT Number: NCT04753229

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ki67 Grade

    Time frame: on pre-operative micro-biopsies

    Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

  2. Ki67 Grade

    Time frame: on surgical specimens

    Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

Secondary outcomes

  1. Percentage of Ki67 positive cells on total counted cells

    Time frame: on preoperative micro-biopsies

    Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

  2. Percentage of Ki67 positive cells on total counted cells

    Time frame: on surgical specimens

    Evaluation by a pathologist by manual counting according to WHO 2017 recommendations

  3. Percentage of Ki67 positive cells on total counted cells

    Time frame: on preoperative micro-biopsies

    Evaluation by digital pathology before and after machine learning

  4. Percentage of Ki67 positive cells on total counted cells

    Time frame: on surgical specimens

    Evaluation by digital pathology before and after machine learning

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: TNE-P-Ki

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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