PrognostIc and Predictive Factors in Unresectable Locally Advanced NEC and MANEC
Retrospective and Prospective Observational Study on prognostIc and Predictive Factors in Patients With Extra-pulmonary, adVanced Neuroendocrine cArciNomas and Mixed Adeno-neuroendocrine Carcinomas (NIRVANA)
European Institute of Oncology
100 participants
Jul 5, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Histological diagnosis of unresectable locally advanced or metastatic NEC or MANEC confirmed by an expert-pathologist
- EP-primary site (included unknown primary site
- Age \> 18 years
- Signed written informed consent
- Performance status ≤2
- Available tumor tissue (formalin-fixed paraffin-embedded, FFPE) (preferably within 6 months). If the tumor contained in FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut. Preferably, 25 slides should be provided (minimum of 15 slides). If tumor tissue is not available, patients should be willing to undergone to a new biopsy.
Exclusion Criteria4
- Diagnosis of well-differentiated NEN (G1, G2, G3)
- Collision tumors
- Cytological diagnosis of NEC or MANEC or not availability of tumor tissue for pathological analysis.
- Concurrent neoplastic disease (e.g. Advanced breast or prostatic cancer in hormonal treatment, hematologic diseases)
Locations(1)
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NCT06400654