Actively Recruiting
Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients: an Observational Prospective Analysis of Functional Imaging and Clinical Outcomes
Led by European Institute of Oncology · Updated on 2024-05-06
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new classification system for a specific type of high-grade neuroendocrine tumors called NET G3, which affect the gastro-entero-pancreatic (GEP) tract. This study aims to better understand the differences within NET G3 tumors, which were officially categorized by the World Health Organization in 2017 and 2019. The goal is to explore clinical, pathological, and radiological factors that may predict patient outcomes and improve diagnosis. This observational study involves patients diagnosed with well-differentiated NET G3 tumors confirmed or reviewed by a specialized pathologist. Participants are expected to provide tumor tissue samples, preferably recent, or undergo a new biopsy if needed. Patients with a history of earlier-stage NET G1/2 tumors must have undergone specific PET/CT scans for review. The study focuses on collecting high-quality data and analyzing tumor characteristics and functional imaging over three years. During the study, researchers will analyze immunohistochemical characteristics and review functional imaging results to correlate with clinical outcomes. Participants will be closely monitored with assessments related to their tumor tissues and imaging scans over a three-year period. The study is designed to enhance understanding of NET G3 tumors and support the development of a detailed prognostic and predictive classification system.
CONDITIONS
Brief Title
Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of well-differentiated neuroendocrine tumor G3 confirmed or reviewed by a NEN-dedicated pathologist
- Age over 18 years
- Signed written informed consent
- Available tumor tissue sample, preferably collected within the last 6 months, or willingness to undergo a new biopsy
- For late-NET G3 patients, prior 68 Gallium-DOTATOC PET/CT and 18 FDG-PET/CT imaging from NET G1/2 history must be available for review
You will not qualify if you...
- Diagnosis of well-differentiated NET G1/2 or poorly-differentiated neuroendocrine carcinoma
- Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) with NET G3 as neuroendocrine component
- Cytological diagnosis of NET G3 without available tumor tissue for pathological analysis
- Presence of other active cancers such as advanced breast or prostate cancer under hormonal treatment or blood-related diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants undergo review of functional imaging and pathological analysis to classify NET G3 tumors and collect high-quality data.
Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
F
Francesca Spada, MD
C
Cristina Mazzon
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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