Risk Factors for Neuroendocrine Neoplasms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBavarian Cancer Registry

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Cases are defined as all persons with a malignant neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023. Controls are defined as noncases in the source population of cases, i.e. persons with a statutory health insurance and at least one outpatient physician contact in Bavaria between 2021 and 2023, whose residence was in Bavaria. Two controls will be sampled for each case.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Case-control study (no intervention)

    Other intervention

    Observation of risk factors in cases and controls

Treatment groups

14,250 Participants
are divided into 2 treatment groups
Group A: Cases1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

Assured NEN diagnosis of the BPS

Neuroendocrine neoplasm of the bronchopulmonary system

Time frame
2021-2023
2

Assured NEN diagnosis of the GEPS

Neuroendocrine neoplasm of the gastroenteropancreatic system

Time frame
2021-2023

Secondary outcomes

1

Assured NET diagnosis of the BPS

Neuroendocrine tumour of the bronchopulmonary system

Time frame
2021-2023
2

Assured NEC diagnosis of the BPS

Neuroendocrine carcinoma of the bronchopulmonary system

Time frame
2021-2023
3

Assured NET diagnosis of the GEPS

Neuroendocrine tumour of the gastroenteropancreatic system

Time frame
2021-2023
4

Assured NEC diagnosis of the GEPS

Neuroendocrine carcinoma of the gastroenteropancreatic system

Time frame
2021-2023

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bavarian Cancer Registry

Lead sponsor

Bavarian Association of Statutory Health Insurance Accredited Physicians

Collaborator