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Cohort of Well-differentiated Grade 3 Neuroendocrine Digestive Tumors (TNE-bien-DIF)

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: NCT04365023
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to analyse clinical data of well-differentiated grade 3 digestive neuroendocrine tumors. These rare tumors may have a different disease evolution, response to chemotherapy and prognostic.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Drug: platinum chemotherapy

Detailed Description:

Digestive neuroendocrine tumors are rare tumors and cell differentiation is a major prognostic marker of neuroendocrine tumors.

The 2010 WHO Classification defined three groups of tumor according to the combination of the morphological characteristics and the mitotic index and/or the Ki-67 index: Grade 1 and 2 corresponded to well differentiated neuroendocrine tumors whereas grade 3 corresponded to poorly differentiated lesions entitled neuroendocrine carcinomas (NEC). It was assumed that no well-differentiated neuroendocrine tumor with a mitotic- or a Ki-67- index above 20% existed.

Recently, a proportion of neuroendocrine tumors corresponding to grade 3 neuroendocrine tumors with a proliferation- or Ki-67 index > 20% and with a well-differentiated morphology have been identified. This entity has been partially explored and may have a different survival than grade 3 NEC. Furthermore, targeted therapies, and used in pancreatic neuroendocrine tumors have not been assessed in this case.

The TENpath network is a pathological network whose goal is the systematic reading of all diagnosed cases of neuroendocrine tumors. As part of this network, nearly 3.000 neuroendocrine tumors were reviewed by pathologist experts. Of all the reviewed tumors, 167 were identified as well-differentiated grade 3 neuroendocrine tumors, observed Ki-67(5.6%) confirming the existence of this entity.

Treatment and follow-up of well-differentiated grade 3 tumors are not consensus-based and recommendations are exclusively based on experts' opinions. The purpose of this study is to define the characterization of this entity and evaluate the efficacy of chemotherapy on well-differentiated grade 3 digestive neuroendocrine tumors identified from the TENpath network.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiological Study of the Therapeutic Management of Well-differentiated Grade 3 (WHO Classification) Neuroendocrine Digestive Tumors From the Prospective Data of the French Neuroendocrine Tumors Registry (GTE)
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive first line platinum based chemotherapy
Drug: platinum chemotherapy
First line platinum chemotherapy

2
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive receiving first line non-platinum chemotherapy



Primary Outcome Measures :
  1. Title : Overall survival [ Time Frame: 12 months ]
    To compare the median of overall survival of Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive first line platinum based chemotherapy versus patients receiving first line non-platinum chemotherapy


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 12 months ]
  2. Progression Free Survival [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
digestive tumors recorded in the national registry of endocrine tumors (GTE) and the TENpath registry
Criteria

Inclusion Criteria:

  • Well-differentiated grade 3 neuroendocrine digestive tumors
  • Patient of 18 years old and more

Exclusion Criteria:

  • Patient opposed to data collection as part of the study
  • Digestive neuroendocrine tumors Grade 1-2
  • Grade 3 poorly differentiated digestive neuroendocrine tumors
  • Malignant disease diagnosed in the last 5 years (except basal cell of the skin and in situ cervical carcinoma)
  • Other non-digestive neuroendocrine tumors
  • Mixed neuroendocrine non neuroendocrine neoplasm

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): NCT04365023


Contacts
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Contact: Romain CORIAR, MD,PhD +33 1 58 41 19 01 romain.coriat@aphp.fr
Contact: Christelle AUGER +33 1 58 41 11 86 christelle.auger@aphp.fr

Locations
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France
Gastroenterology and digestive oncology unit - Cochin hospital
Paris, France, 75014
Contact: Romain Coriat, MD, PhD    +33 1 58 41 19 01    romain.coriat@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ipsen
Investigators
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Principal Investigator: Romain CORIAT, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04365023    
Other Study ID Numbers: NI18009HLJ
2019-A00404-53 ( Registry Identifier: ID-RCB )
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Assistance Publique - Hôpitaux de Paris:
Neuroendocrine Tumors
Epidemiology
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue