PrognostIc and Predictive Factors in Unresectable Locally Advanced NEC and MANEC

NCT06400654 | Recruiting

• 1 other identifier: IEO 1476
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Carcinoma

Keywords

poorly differentiated neuroendocrine carcinoma; mixed adeno-neuroendocrine carcinoma; prognostic factor; predictive factor

Outcome Measures

Primary Outcomes (1)

• Overall survival clinical outcome

  The primary clinical endpoint will be the overall survival.

  3 years

Secondary Outcomes (3)

• Progression free survival clinical outcome

  3 years

• Mutational pattern

  3 years

• Prognostic and predictive factors identification

  3 years

Study Arms (2)

unresectable locally advanced neuroendocrine carcinoma

patients with extra-pulmonary, advanced neuroendocrine carcinomas

mixed Adeno-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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue samples, peripheral blood samples

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Francesca Spada, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Spada, MD

CONTACT

+390257489258; divisione.gastrointestinale@ieo.it

Cristina Mazzon

CONTACT

cristina.mazzon@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: May 6, 2024
• Study Start: July 5, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)