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
|Condition or disease||Intervention/treatment|
|Neuroendocrine Tumors||Drug: platinum chemotherapy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive first line platinum based chemotherapy
Drug: platinum chemotherapy
First line platinum chemotherapy
Well-differentiated grade 3 gastrointestinal neuroendocrine tumors patients who receive receiving first line non-platinum chemotherapy
- 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
- Objective response rate [ Time Frame: 12 months ]
- Progression Free Survival [ Time Frame: 12 months ]
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
|Contact: Romain CORIAR, MD,PhD||+33 1 58 41 19 firstname.lastname@example.org|
|Contact: Christelle AUGER||+33 1 58 41 11 email@example.com|
|Gastroenterology and digestive oncology unit - Cochin hospital|
|Paris, France, 75014|
|Contact: Romain Coriat, MD, PhD +33 1 58 41 19 01 firstname.lastname@example.org|
|Principal Investigator:||Romain CORIAT, MD, PhD||Assistance Publique - Hôpitaux de Paris|