Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
1 other identifier
observational
250
1 country
1
Brief Summary
Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas. pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2019
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedOctober 22, 2019
October 1, 2019
11 months
October 18, 2019
October 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The survival will be evaluated by Kaplan Meier Method. The prognostic factors will be evaluated with univariate and multivariate analysis by Cox regression model.
The participant will be followed-up for a maximum of 11 years, and 1 year at least.
Eligibility Criteria
Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma, with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease and covered in one of the participating centres between 01/01/2008 and 01/01/2019
You may qualify if:
- Major topic ((≥18 years)
- Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma
- Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease.
- Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019
- Have a pre-therapeutic biological check-up
- Subject who has not expressed opposition to the use of his or her data for research purposes
You may not qualify if:
- Subject who expressed opposition to participate in the study
- Lack of histological data
- Minor subject
- Patient under the protection of justice
- Subject under guardianship or trusteeship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service D'Hematologie Et D'Oncologie
Strasbourg, 67098, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 22, 2019
Study Start
June 27, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
October 22, 2019
Record last verified: 2019-10