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

NCT06402695 | Recruiting DMC

• 1 other identifier: 5981
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; Gep Net; Pulmonary Neuroendocrine Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The length of time from the date of diagnosis to death.

  from randomization to end of study or death event (estimed: up to 36 months).

Secondary Outcomes (1)

• Progression Free Survival

  from randomization to progression or death event or end of the study (estimed: up to 36 months).

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 18 years affected by gastroenteropancreatic or pulmonary NET.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Gastro-enteropancreatic neuroendocrine tumor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Giovanni Schinzari

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Grazia Maratta, MD

CONTACT

+39 0630156318; mariagrazia.maratta@guest.policlinicogemelli.it

Giovanni Schinzari, MD

CONTACT

+39 0630156318; giovanni.schinzari@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: September 15, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-04

Locations

IT (1)