NCT04134832

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 18, 2019

Last Update Submit

October 18, 2019

Conditions

Keywords

Pancreatic neuroendocrine tumorsNeutrophil-to-lymphocyte ratio

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

RECRUITING

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

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

Locations