Cohort of Well-differentiated Grade 3 Neuroendocrine Digestive Tumors
NCT ID: NCT04365023
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2020-07-02
2023-05-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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1
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive first line platinum based chemotherapy
platinum chemotherapy
First line platinum chemotherapy
2
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive receiving first line non-platinum chemotherapy
No interventions assigned to this group
Interventions
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platinum chemotherapy
First line platinum chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Patient of 18 years old and more
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Romain CORIAT, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Gastroenterology and digestive oncology unit - Cochin hospital
Paris, , France
Countries
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Other Identifiers
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2019-A00404-53
Identifier Type: REGISTRY
Identifier Source: secondary_id
NI18009HLJ
Identifier Type: -
Identifier Source: org_study_id
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