Risk Factors for Neuroendocrine Neoplasms

NCT06282016 | Recruiting

• 1 other identifier: BKR-2024-001
• Study Type: observational
• Target: 14,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Neoplasm of Lung; Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)

Keywords

Neuroendocrine neoplasms; Colorectal cancer; Risk factors; Case-Control Study; Cancer Registry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assured NET diagnosis of the BPS

  2021-2023

• Assured NEC diagnosis of the BPS

  2021-2023

• Assured NET diagnosis of the GEPS

  2021-2023

• Assured NEC diagnosis of the GEPS

  2021-2023

Study Arms (2)

Cases

Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed between 2021 and 2023

Other: Case-control study (no intervention)

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)

Interventions

Case-control study (no intervention) OTHER

Observation of risk factors in cases and controls

Cases; Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Bavarian Cancer Registry: lead
• Bavarian Association of Statutory Health Insurance Accredited Physicians: collaborator

Study Sites (1)

Bavarian Cancer Registry, Bavarian Health and Food Safety Authority

Nuremberg, Bavaria, 90441, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40409959 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Case-Control Studies

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jacqueline Müller-Nordhorn

  Bavarian Cancer Registry, Bavarian Health and Food Safety Authority

  PRINCIPAL INVESTIGATOR

• Martin Tauscher

  Bavarian Association of Statutory Health Insurance Accredited Physicians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Voigtländer

CONTACT

+49-(0)9131-6808; sven.voigtlaender@lgl.bayern.de

Jacqueline Müller-Nordhorn

CONTACT

+49-(0)9131-6808; jacqueline.mueller-nordhorn@lgl.bayern.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 28, 2024
• Study Start: May 15, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)