Comparison of the Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia Between Preoperative Micro-biopsies and Surgical Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Ki67 Grade
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Ki67 Grade
时间窗: on surgical specimens
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
次要结局
- Percentage of Ki67 positive cells on total counted cells(on surgical specimens)