Risk Factors for Neuroendocrine Neoplasms

NCT ID: NCT06282016

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

14250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

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

Case-control study (no intervention)

Intervention Type OTHER

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)

Case-control study (no intervention)

Intervention Type OTHER

Observation of risk factors in cases and controls

Interventions

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Case-control study (no intervention)

Observation of risk factors in cases and controls

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bavarian Association of Statutory Health Insurance Accredited Physicians

UNKNOWN

Sponsor Role collaborator

Bavarian Cancer Registry

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline Müller-Nordhorn

Role: PRINCIPAL_INVESTIGATOR

Bavarian Cancer Registry, Bavarian Health and Food Safety Authority

Martin Tauscher

Role: PRINCIPAL_INVESTIGATOR

Bavarian Association of Statutory Health Insurance Accredited Physicians

Locations

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Bavarian Cancer Registry, Bavarian Health and Food Safety Authority

Nuremberg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sven Voigtländer

Role: CONTACT

+49-(0)9131-6808 ext. 2927

Jacqueline Müller-Nordhorn

Role: CONTACT

+49-(0)9131-6808 ext. 4331

Facility Contacts

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Martin Meyer, Dr.

Role: primary

+49 (0)9131 6808-2920

References

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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.

Reference Type DERIVED
PMID: 40409959 (View on PubMed)

Other Identifiers

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BKR-2024-001

Identifier Type: -

Identifier Source: org_study_id

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