Understanding factors in advanced neuroendocrine carcinomas
Retrospective and Prospective Observational Study on prognostIc and Predictive Factors in Patients With Extra-pulmonary, adVanced Neuroendocrine cArciNomas and Mixed Adeno-neuroendocrine Carcinomas (NIRVANA)
This study is looking at rare and aggressive tumors called neuroendocrine carcinomas to see what factors affect them and how to create better treatment plans for patients with advanced cases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06400654 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on extra-pulmonary poorly differentiated neuroendocrine carcinomas (NECs) and mixed adeno-neuroendocrine carcinomas (MANEC), which are rare and aggressive tumors. The study aims to characterize these neoplasms through clinical, morphological, and biomolecular assessments, addressing the lack of universal clinical guidelines for their management. Patients with unresectable locally advanced or metastatic NEC or MANEC will be included, and their tumor tissues will be analyzed to identify prognostic and predictive factors. The findings may help in developing tailored treatment approaches for affected patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unresectable locally advanced or metastatic NEC or MANEC confirmed by an expert pathologist.
Not a fit: Patients with well-differentiated neuroendocrine neoplasms or those with concurrent neoplastic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management strategies for patients with advanced neuroendocrine carcinomas.
How similar studies have performed: While studies on neuroendocrine tumors exist, the specific focus on poorly differentiated NECs and MANECs is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Spada, MD — Istituto Europeo di Oncologia
- Study coordinator: Francesca Spada, MD
- Email: divisione.gastrointestinale@ieo.it
- Phone: +390257489258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.