Observational Study on GEP-and Pulm-NET Treated at FPG

NCT ID: NCT06402695

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2026-07-31

Brief Summary

Observational ambispective monocentric study on the clinical, laboratory, pathological and molecular characteristics of patients suffering from gastroenteropancreatic tract and pulmonary neuroendocrine tumors and their prognostic and predictive value.

Detailed Description

Neuroendocrine tumors (NETs) are a heterogeneous group of rare epithelial neoplasms arising from cells of the diffuse neuroendocrine system. In recent years their incidence has been constantly increasing and up to 80% of cases already begin in an advanced stage. The most frequent site of primary localization is the gastroenteropancreatic tract (GEP-NET) in 60% of cases, followed, in 25%, by the lung (L-NET). Clinically, NETs are classified as functioning (F) or non-functioning (NF) based on the presence of symptoms caused by hormonal secretion produced by tumor cells. NETs are characterized by great clinical and biological, inter- and intra-tumoral heterogeneity. The WHO classification identifies four categories: well-differentiated NETs, G1, G2 and G3, and poorly differentiated neuroendocrine carcinomas (NECs), which represent 10%-20% of all neuroendocrine neoplasms. This classification, together with the TNM stage according to the American Joint Committee on Cancer (AJCC 8th edition) takes on an important prognostic value. However, these two criteria are not exhaustive in predicting the aggressiveness of the pathology nor the response to oncological therapies. There is therefore a clear clinical need, to date unsatisfied, for new prognostic and predictive biomarkers, which can better define the heterogeneity of NETs by implementing classification and staging, to guide prognosis and support therapeutic decisions.

The main feature of all well-differentiated NETs is the overexpression of the somatostatin receptor, measured by PCR-based or immunohistochemistry (IHC)-based methods or by imaging. Among these receptors, the SSTR2A subtype is the most commonly expressed. Diagnostic and therapeutic approaches aimed at SSTR have shown advantages but it is not clear how much the degree of expression of SSTR in positive patients influences the response to treatment and whether it has a correlation with survival, regardless of the oncological treatments used. Furthermore, since the expression of this receptor appears inversely proportional to the degree of differentiation and can be different within the same disease between primary tumor and metastatic disease, this receptor could have a further role as a measure of tumor heterogeneity and disease progression.

Conditions

Neuroendocrine Tumors; Gep Net; Pulmonary Neuroendocrine Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

retrospective cohort

GEP- and Pulm- NET patients referred to the U.O.C. of Medical Oncology of the FPG - IRCCS since 01/01/2010 up to the date of approval of the study.

No interventions assigned to this group

prospective cohort

GEP- and Pulm- NET patients referred to the U.O.C. of Medical Oncology of the FPG - IRCCS starting from the date of approval of the study for the following 36 months.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• histological diagnosis of gastroenteropancreatic or pulmonary NET
• age ≥ 18 years;
• radiological evidence of resectable/locally advanced/metastatic disease;
• signing of informed consent;
• at least one visit following the first oncological visit.

Exclusion Criteria

• absence of clinical data that allow adequate definition of survival (primary endpoint of the study);
• absence of histological diagnosis;
• failure to sign the informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Schinzari

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Grazia Maratta, MD

Role: CONTACT

mariagrazia.maratta@guest.policlinicogemelli.it

+39 0630156318

Giovanni Schinzari, MD

Role: CONTACT

giovanni.schinzari@policlinicogemelli.it

+39 0630156318

Facility Contacts

Maria Grazia Maratta

Role: primary

mariagrazia.maratta@guest.policlinicogemelli.it

Giovanni Schinzari

Role: backup

giovanni.schinzari@policlinicogemelli.it

Other Identifiers

5981

Identifier Type: -

Identifier Source: org_study_id