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Clinical Trials/NCT06282016
NCT06282016RecruitingNot Applicable

Risk Factors for Neuroendocrine Neoplasms: a Case-control Study Based on a Record Linkage of Registry and Claims Data

Bavarian Cancer Registry1 site in 1 country14,250 target enrollmentStarted: May 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
14,250
Locations
1
Primary Endpoint
Assured NEN diagnosis of the BPS

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Outcomes

Primary Outcomes

Assured NEN diagnosis of the BPS

Time Frame: 2021-2023

Neuroendocrine neoplasm of the bronchopulmonary system

Assured NEN diagnosis of the GEPS

Time Frame: 2021-2023

Neuroendocrine neoplasm of the gastroenteropancreatic system

Secondary Outcomes

  • Assured NET diagnosis of the BPS(2021-2023)
  • Assured NEC diagnosis of the BPS(2021-2023)
  • Assured NEC diagnosis of the GEPS(2021-2023)
  • Assured NET diagnosis of the GEPS(2021-2023)

Investigators

Sponsor
Bavarian Cancer Registry
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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