Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134832
• Other study ID #: 7435
• Status: Recruiting
• Start date: June 27, 2019
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: University Hospital, Strasbourg, France
• Contact: Gabriel MALOUF, MD, PhD
• Phone: 33 3 88 11 62 22
• Email: gabriel.malouf[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Major topic ((=18 years)

2. Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma

3. Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease.

4. Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019

5. Have a pre-therapeutic biological check-up

6. Subject who has not expressed opposition to the use of his or her data for research purposes

Exclusion criteria:

1. Subject who expressed opposition to participate in the study

2. Lack of histological data

3. Minor subject

4. Patient under the protection of justice

5. Subject under guardianship or trusteeship

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Locations

Country	Name	City	State
France	Service D'Hematologie Et D'Oncologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.