Risk Factors for Neuroendocrine Neoplasms

Not yet recruiting

• Conditions: Neuroendocrine Neoplasm of Lung; Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
• Interventions: Other: Case-control study (no intervention)

• Registration Number: NCT06282016
• Lead Sponsor: Bavarian Cancer Registry

Brief Summary

Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Start: 2025-05-15
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14250

Inclusion Criteria

• Persons with a statutory health insurance (about 85% of the population) and at least one outpatient physician contact in Bavaria between 2021 and 2023
• Residence in Bavaria

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Case-control study (no intervention)	Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed in the years 2020 or 2021
Controls	Case-control study (no intervention)	Patients without a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed in the years 2020 or 2021 (=no documented diagnosis of neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system in the Bavarian Cancer Registry)

Primary Outcome Measures

Name	Time	Method
Assured NEN diagnosis of the BPS	2021-2023	Neuroendocrine neoplasm of the bronchopulmonary system
Assured NEN diagnosis of the GEPS	2021-2023	Neuroendocrine neoplasm of the gastroenteropancreatic system

Secondary Outcome Measures

Name	Time	Method
Assured NET diagnosis of the BPS	2021-2023	Neuroendocrine tumour of the bronchopulmonary system
Assured NEC diagnosis of the BPS	2021-2023	Neuroendocrine carcinoma of the bronchopulmonary system
Assured NEC diagnosis of the GEPS	2021-2023	Neuroendocrine carcinoma of the gastroenteropancreatic system
Assured NET diagnosis of the GEPS	2021-2023	Neuroendocrine tumour of the gastroenteropancreatic system