Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134832
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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


Condition or disease
Pancreatic Neuroendocrine Tumor

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020





Primary Outcome Measures :
  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. [ Time Frame: The participant will be followed-up for a maximum of 11 years, and 1 year at least. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134832


Contacts
Layout table for location contacts
Contact: Gabriel MALOUF, MD, PhD 33 3 88 11 62 22 gabriel.malouf@chru-strasbourg.fr

Locations
Layout table for location information
France
Service D'Hematologie Et D'Oncologie Recruiting
Strasbourg, France, 67098
Contact: Gabriel MALOUF, MD, PhD    33 3 88 11 62 22    gabriel.malouf@chru-strasbourg.fr   
Principal Investigator: Gabriel MALOUF, MD, PhD         
Sub-Investigator: Jean-Marc Limacher, MD         
Sub-Investigator: Emmanuel Achille         
Sub-Investigator: Louis-Marie Dourthe         
Sub-Investigator: Bernard Willemin         
Sub-Investigator: Stéphanie Husson         
Sub-Investigator: Meher Ben Abdelghani         
Sub-Investigator: Véronique Debien         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04134832    
Other Study ID Numbers: 7435
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Pancreatic neuroendocrine tumors
Neutrophil-to-lymphocyte ratio
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenoma
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases