Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia

Neuroendocrine Tumors Clinical Trial

— TNE-P-Ki  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753229
• Other study ID #: TNE P Ki-IPC 2020-046
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ki67 Grade	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on pre-operative micro-biopsies
Primary	Ki67 Grade	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on surgical specimens
Secondary	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
Secondary	Percentage of Ki67 positive cells on total counted cells	Evaluation by a pathologist by manual counting according to WHO 2017 recommendations	on surgical specimens
Secondary	Percentage of Ki67 positive cells on total counted cells	Evaluation by digital pathology before and after machine learning	on preoperative micro-biopsies
Secondary	Percentage of Ki67 positive cells on total counted cells	Evaluation by digital pathology before and after machine learning	on surgical specimens