Risk Factors for Neuroendocrine Neoplasms

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

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 Overview

• Status: Recruiting
• Conditions: Neuroendocrine Neoplasm of Lung; Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
• Intervention / Treatment: Other: Case-control study (no intervention)

• Study Type: Observational
• Enrollment (Estimated): 14250

Contacts and Locations

• Study Contact: Name: Sven Voigtländer; Phone Number: 2927 +49-(0)9131-6808; Email: sven.voigtlaender@lgl.bayern.de
• Study Contact Backup: Name: Jacqueline Müller-Nordhorn; Phone Number: 4331 +49-(0)9131-6808; Email: jacqueline.mueller-nordhorn@lgl.bayern.de

Study Locations

• Germany
  • Bavaria
    • Nuremberg, Bavaria, Germany, 90441
      • Recruiting
      • Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
      • Contact: Martin Meyer, Dr.; Phone Number: +49 (0)9131 6808-2920; Email: martin.meyer@lgl.bayern.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023	Other: Case-control study (no intervention); Observation of risk factors in cases and controls
Controls; Patients without a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023 (=no documented diagnosis of neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system in the Bavarian Cancer Registry)	Other: Case-control study (no intervention); Observation of risk factors in cases and controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assured NEN diagnosis of the BPS	Neuroendocrine neoplasm of the bronchopulmonary system	2021-2023
Assured NEN diagnosis of the GEPS	Neuroendocrine neoplasm of the gastroenteropancreatic system	2021-2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assured NET diagnosis of the BPS	Neuroendocrine tumour of the bronchopulmonary system	2021-2023
Assured NEC diagnosis of the BPS	Neuroendocrine carcinoma of the bronchopulmonary system	2021-2023
Assured NET diagnosis of the GEPS	Neuroendocrine tumour of the gastroenteropancreatic system	2021-2023
Assured NEC diagnosis of the GEPS	Neuroendocrine carcinoma of the gastroenteropancreatic system	2021-2023

Collaborators and Investigators

• Sponsor: Bavarian Cancer Registry
• Collaborators: Bavarian Association of Statutory Health Insurance Accredited Physicians
• Investigators: Principal Investigator: Jacqueline Müller-Nordhorn, Bavarian Cancer Registry, Bavarian Health and Food Safety Authority; Principal Investigator: Martin Tauscher, Bavarian Association of Statutory Health Insurance Accredited Physicians

Publications and helpful links

General Publications

• Voigtlander S, Gerlach R, Grundmann N, Donnachie E, Berger U, Hakimhashemi A, Meyer M, Tauscher M, Muller-Nordhorn J. Risk factors for neuroendocrine neoplasms: protocol for a case-control study based on a record linkage of registry and claims data. BMJ Open. 2025 May 23;15(5):e096273. doi: 10.1136/bmjopen-2024-096273.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer; Risk factors; Case-Control Study; Neuroendocrine neoplasms; Cancer Registry
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Studies; Epidemiologic Study Characteristics; Case-Control Studies
• Other Study ID Numbers: BKR-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No