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CompletedNCT04365023TNE-bien-DIFUpdated Feb 13, 2026

Cohort of Well-differentiated Grade 3 Neuroendocrine Digestive Tumors

An observational study in Neuroendocrine Tumors, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
168
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neuroendocrine Tumors

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Keywords

  • Neuroendocrine Tumors
  • Epidemiology
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 168 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

digestive tumors recorded in the national registry of endocrine tumors (GTE) and the TENpath registry

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
168 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive first line platinum based chemotherapy

    Drug: platinum chemotherapy

  • 2

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

Interventions

  • Drugplatinum chemotherapy

    First line platinum chemotherapy

06

What researchers measure

Primary outcomes

  1. Title : Overall survival

    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

    Time frame: 12 months

Secondary outcomes

  1. Objective response rate

    Time frame: 12 months

  2. Progression Free Survival

    Time frame: 12 months

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Study locations

1 site
  • Gastroenterology and digestive oncology unit - Cochin hospital
    Paris, 75014, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04365023
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ipsen, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Apr 28, 2020
Start date
Jul 2, 2020
Primary completion
May 25, 2023
Completion
May 25, 2023
Last update
Feb 13, 2026

Study contacts

Romain CORIAT, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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