NCT04365023

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

April 25, 2020

Last Update Submit

February 11, 2026

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine TumorsEpidemiology

Outcome Measures

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

    12 months

Secondary Outcomes (2)

  • Objective response rate

    12 months

  • Progression Free Survival

    12 months

Study Arms (2)

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

platinum chemotherapyDRUG

First line platinum chemotherapy

1

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology and digestive oncology unit - Cochin hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Romain CORIAT, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

July 2, 2020

Primary Completion

May 25, 2023

Study Completion

May 25, 2023

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)