Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- unresectable locally advanced neuroendocrine carcinoma
- description
- patients with extra-pulmonary, advanced neuroendocrine carcinomas
- label
- mixed Adeno-neuroendocrine carcinomas
- description
- 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
Primary outcomes (1)
- measure
- Overall survival clinical outcome
- timeFrame
- 3 years
- description
- The primary clinical endpoint will be the overall survival.
Secondary outcomes (3)
- measure
- Progression free survival clinical outcome
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (0)
Data not yet available