Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data

Background Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obe...

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Main Authors: Nina Grundmann, Jacqueline Müller-Nordhorn, Ursula Berger, Sven Voigtländer, Ewan Donnachie, Martin Tauscher, Roman Gerlach, Amir Hakimhashemi, Martin Meyer
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/5/e096273.full
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author Nina Grundmann
Jacqueline Müller-Nordhorn
Ursula Berger
Sven Voigtländer
Ewan Donnachie
Martin Tauscher
Roman Gerlach
Amir Hakimhashemi
Martin Meyer
author_facet Nina Grundmann
Jacqueline Müller-Nordhorn
Ursula Berger
Sven Voigtländer
Ewan Donnachie
Martin Tauscher
Roman Gerlach
Amir Hakimhashemi
Martin Meyer
author_sort Nina Grundmann
collection DOAJ
description Background Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.Methods and analysis A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.Ethics and dissemination This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.Trial registration number NCT06282016.
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spelling doaj-art-e60aebf4985a4cbf9bc72dbd0bebb68f2025-08-20T03:13:43ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-096273Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims dataNina Grundmann0Jacqueline Müller-Nordhorn1Ursula Berger2Sven Voigtländer3Ewan Donnachie4Martin Tauscher5Roman Gerlach6Amir Hakimhashemi7Martin Meyer8Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Nuremberg, GermanyBavarian Cancer Registry, Bavarian Health and Food Safety Authority, Nuremberg, GermanyInstitute for Medical Information Processing, Biometry, and Epidemiology, Faculty of Medicine, Ludwig-Maximilians-Universität, Munich, GermanyBavarian Cancer Registry, Bavarian Health and Food Safety Authority, Nuremberg, GermanyBavarian Association of Statutory Health Insurance Accredited Physicians, Munich, GermanyBavarian Association of Statutory Health Insurance Accredited Physicians, Munich, GermanyBavarian Association of Statutory Health Insurance Accredited Physicians, Munich, GermanyBavarian Cancer Registry, Bavarian Health and Food Safety Authority, Nuremberg, GermanyBavarian Cancer Registry, Bavarian Health and Food Safety Authority, Nuremberg, GermanyBackground Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.Methods and analysis A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.Ethics and dissemination This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.Trial registration number NCT06282016.https://bmjopen.bmj.com/content/15/5/e096273.full
spellingShingle Nina Grundmann
Jacqueline Müller-Nordhorn
Ursula Berger
Sven Voigtländer
Ewan Donnachie
Martin Tauscher
Roman Gerlach
Amir Hakimhashemi
Martin Meyer
Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
BMJ Open
title Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
title_full Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
title_fullStr Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
title_full_unstemmed Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
title_short Risk factors for neuroendocrine neoplasms: protocol for a case–control study based on a record linkage of registry and claims data
title_sort risk factors for neuroendocrine neoplasms protocol for a case control study based on a record linkage of registry and claims data
url https://bmjopen.bmj.com/content/15/5/e096273.full
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