Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402695
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-03
Brief Title:
Observational Study on GEP-and Pulm-NET Treated at FPG
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Observational Study on Clinical Laboratory Anatomopathological and Molecular Characteristics and Their Prognostic and Predictive Value in Patients With Neuroendocrine Tumors of the Gastroenteropancreatic Tract and Pulmonary Treated at Fondazione Policlinico Agostino Gemelli FPG-IRCCS
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETNA-FPG
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None