An observational study in Neuroendocrine Carcinoma, sponsored by European Institute of Oncology. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by European Institute of Oncology · Observational
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.
Extra-pulmonary (EP) poorly differentiated neuroendocrine carcinomas (NECs) represent a rare and aggressive category of neoplasms. They occur in almost 1 / 100.000 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 0.1 / 100.000 / 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-fluorouracil/folinic-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.
238 studies on the registry are indexed under Carcinoma, Neuroendocrine; 65 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 38 observational studies indexed under Carcinoma, Neuroendocrine.
Browse Carcinoma, Neuroendocrine studies →European Institute of Oncology is the lead sponsor of 184 studies on the registry; 117 are open to participants now.
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Extra-pulmonary (EP) poorly differentiated neuroendocrine carcinomas (NECs) and mixed neuroendocrine non-neuroendocrine neoplasms (MINENs) patients aged more than 18 years with ECOG PS minor or equal to 2.
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Exclusion Criteria:
patients with extra-pulmonary, advanced neuroendocrine carcinomas
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
Overall survival clinical outcome
The primary clinical endpoint will be the overall survival.
Time frame: 3 years
Progression free survival clinical outcome
The secondary clinical endpoint will be the progression free survival
Time frame: 3 years
Mutational pattern
Mutational patterns such as BRAF, KRAS, NRAS, MSI, TP53, RB1 will be analyzed.
Time frame: 3 years
Prognostic and predictive factors identification
The progression free survival and overall survival of patients with mutations will be evaluated.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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European Institute of Oncology →