Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400654
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-18
Brief Title:
PrognostIc and Predictive Factors in Unresectable Locally Advanced NEC and MANEC
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Retrospective and Prospective Observational Study on prognostIc and Predictive Factors in Patients With Extra-pulmonary adVanced Neuroendocrine cArciNomas and Mixed Adeno-neuroendocrine Carcinomas NIRVANA
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIRVANA
Brief Summary:
Extra-pulmonary EP poorly differentiated neuroendocrine carcinomas NECs represent a rare and aggressive category of neoplasms Mixed adeno-neuroendocrine carcinomas MANEC are a group of rare neoplasms composed by a neuroendocrine NE and a non-neuroendocrine non-NE component each representing at least the 30 of the neoplasm
Considering their rarity low prevalence and poor prognosis a clear clinical morphological and biomolecular characterization of these neoplasms has been prevented and a clinical approach universally shared is still lacking
Considering their rarity low prevalence and poor prognosis a clear clinical morphological and biomolecular characterization of these neoplasms has been prevented and a clinical approach universally shared is still lacking
Detailed Description:
Extra-pulmonary EP poorly differentiated neuroendocrine carcinomas NECs represent a rare and aggressive category of neoplasms They occur in almost 1 100000 patients and the largest part is represented by gastro-entero-pancreatic GEP NECs 39
Moreover mixed neuroendocrine non-neuroendocrine neoplasms MiNENs represent an even more rare entity with a crude incidence of 01 100000 year composed at least by 30 of a neuroendocrine NE and a non-neuroendocrine non-NE component based on the 2019 World Health Organization WHO classification Focusing on the neuroendocrine counterpart although the term MiNEN includes both well and poorly differentiated morphologies the main part of them are represented by high grade neuroendocrine neoplasms categorized as MANECs in previous 2010 WHO classification that is a term still used in clinical practice is still lacking
While for localized disease surgery represents the cornerstone and virtually the unique curative approach patients with metastatic disease are mostly managed with chemotherapy Although any specific clinical practice guideline by Oncological and or Neuroendocrine Societies has been yet developed worldwide based on the clinical and morphological similarity with small and large cell lung NECs cis carbo-platinum based chemotherapy is the most often chemotherapeutic regimen proposed in clinical practice both in NECs and MANECs from each site of origin Other proposed options include regimens containing 5-fluorouracilfolinic-acid and irinotecan or oxaliplatin which are used also in the treatment of colo-rectal adenocarcinomas Moreover considering their rarity low prevalence and poor prognosis a clear clinical morphological and biomolecular characterization of these neoplasms has been prevented and a clinical approach universally shared is still lacking
Therefore a comprehensive clinical and biological characterization of these neoplasms represents an unmet medical need and a major challenge and could improve the awareness of clinicians in the management of EP-NECs and MANECs
Moreover mixed neuroendocrine non-neuroendocrine neoplasms MiNENs represent an even more rare entity with a crude incidence of 01 100000 year composed at least by 30 of a neuroendocrine NE and a non-neuroendocrine non-NE component based on the 2019 World Health Organization WHO classification Focusing on the neuroendocrine counterpart although the term MiNEN includes both well and poorly differentiated morphologies the main part of them are represented by high grade neuroendocrine neoplasms categorized as MANECs in previous 2010 WHO classification that is a term still used in clinical practice is still lacking
While for localized disease surgery represents the cornerstone and virtually the unique curative approach patients with metastatic disease are mostly managed with chemotherapy Although any specific clinical practice guideline by Oncological and or Neuroendocrine Societies has been yet developed worldwide based on the clinical and morphological similarity with small and large cell lung NECs cis carbo-platinum based chemotherapy is the most often chemotherapeutic regimen proposed in clinical practice both in NECs and MANECs from each site of origin Other proposed options include regimens containing 5-fluorouracilfolinic-acid and irinotecan or oxaliplatin which are used also in the treatment of colo-rectal adenocarcinomas Moreover considering their rarity low prevalence and poor prognosis a clear clinical morphological and biomolecular characterization of these neoplasms has been prevented and a clinical approach universally shared is still lacking
Therefore a comprehensive clinical and biological characterization of these neoplasms represents an unmet medical need and a major challenge and could improve the awareness of clinicians in the management of EP-NECs and MANECs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None