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Trial record 13 of 1322 for:    survival | Neuroendocrine Tumors

Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System (PanTEN)

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ClinicalTrials.gov Identifier: NCT03791346
Recruitment Status : Completed
First Posted : January 1, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France
Department of oncology, Carémeau Hospital, 30900, Nîmes, France
Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France
Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in pancreatic neuroendocrine tumor (PanNET) patients.

Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of overall survival (OS) and disease free survival (DFS) were evaluated.


Condition or disease
Pancreatic Surgery

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Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.
Actual Study Start Date : January 1, 1997
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disease-free survival at 5 years [ Time Frame: 5 years ]
    Disease-free survival (percentage of patients without recurrence) at 5 years. Disease-free survival (DFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause)


Secondary Outcome Measures :
  1. Overall survival at 5 years [ Time Frame: 5 years ]
    Overall survival (OS) (time from diagnosis until death, regardless of cause)



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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
Retrospective review of collected data including all consecutive patients requiring a pancreatic resection for PanNET at 3 tertiary referral centers for pancreatic surgery in France, between December 1997 and December 2017. The 3 centers were Digestive Surgery Units of Montpellier, Nimes and Institute of Cancer at the University of Montpellier-Nimes.
Criteria

Inclusion criteria:

- patients with histologically proven neuroendocrine tumor located in pancreas who underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of distant metastasis at time of surgery, with no previous or concurrent malignancy.

Exclusion criteria:

- Patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or with focal neuroendocrine component were excluded of this study.


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): NCT03791346


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France
Department of oncology, Carémeau Hospital, 30900, Nîmes, France
Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France
Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France
Investigators
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Study Director: REGIS SOUCHE University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03791346     History of Changes
Other Study ID Numbers: RECHMPL18_0492
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
neuroendocrine tumor
Survival
WHO 2017 grading system
pancreatectomy
Laparoscopy
Postoperative outcomes
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue