Understanding high-grade neuroendocrine tumors G3

Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients: an observAtional, Prospective Analysis of the Correlation Between Functional Imaging and Clinical Outcome (TAPIOCA)

This study is trying to find better ways to classify and understand high-grade neuroendocrine tumors in patients to improve their treatment and outcomes.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: European Institute of Oncology (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT06343428 on ClinicalTrials.gov

What this trial studies

This observational study aims to define a multiparametric prognostic and predictive classification system for patients with high-grade neuroendocrine tumors (NETs) G3. It builds on previous findings that suggest significant clinical, pathological, and radiological heterogeneity among NET G3 patients. By systematically collecting high-quality data and correlating various features, the study seeks to identify distinct prognostic subcategories within NET G3. The ultimate goal is to enhance understanding of this complex pathology and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with a histological diagnosis of well-differentiated neuroendocrine tumor G3.

Not a fit: Patients with poorly-differentiated neuroendocrine carcinomas or those without available tumor tissue may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate prognostic assessments and tailored treatment strategies for patients with NET G3.

How similar studies have performed: While there have been studies on neuroendocrine tumors, this specific approach to classifying NET G3 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

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

Conditions Neuroendocrine Neoplasm; High-grade neuroendocrine neoplasm; prognostic factor; predictive factor