Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients

NCT06343428 | Recruiting

• 1 other identifier: IEO 1519
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs. The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs). However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed.

Conditions

Neuroendocrine Neoplasm

Keywords

High-grade neuroendocrine neoplasm; prognostic factor; predictive factor

Outcome Measures

Primary Outcomes (1)

• Immunohistochemical characteristics analysis

  Analysis of the morphology Analysis of proliferation index Ki-67 Analysis of Ki-67 expression (as hotspot or a diffuse expression on the sample) Analysis of Synaptophysin, and chromogranin expression

  3 years

Secondary Outcomes (1)

• Review of the functional imaging

  3 years

Study Arms (1)

NET G3 patients

Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NET G3 patients managed at IEO. Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.

You may qualify if:

• Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" (see Patients and Methods), a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.
• Age \> 18 years
• Signed written informed consent
• 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.
• late-NET G3 patients that will come to our Institute at the moment of NET G3 diagnosis will be enrolled only if they performed 68 Gallium-DOTATOC positron emission tomography (PET)/CT and 18 fluorodeoxyglucose (FDG)-PET/CT for the previous NET G1/2. The previous functional imaging performed during the NET G1/2 history shall be available for the review by our specialist in nuclear medicine.

You may not qualify if:

• Diagnosis of well-differentiated NET G1/2 or poorly-differentiated NEC
• Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) in which a NET G3 as neuroendocrine component
• Cytological diagnosis of NET G3 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

blood sample, tumor tissue

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: July 19, 2021
• Primary Completion: July 19, 2024
• Study Completion (Estimated): July 19, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)