Risk Factors for Neuroendocrine Neoplasms

Neuroendocrine Neoplasm of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282016
• Other study ID #: BKR-2024-001
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Bavarian Cancer Registry
• Contact: Sven Voigtländer
• Phone: +49-(0)9131-6808
• Email: sven.voigtlaender[@]lgl.bayern.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Resident in Bavaria for the years 2020 and 2021

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lung Neoplasms
• Neoplasms
• Neuroendocrine Neoplasm of Lung
• Neuroendocrine Tumors

Intervention

Other:
• Case-control study (no intervention)
Observation of risk factors in cases and controls

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Cancer Registry	Bavarian Association of Statutory Health Insurance Accredited Physicians

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression/Persistent mood disorder	Assured ICD-10 diagnosis F32, F33, or F34 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Obesity	Assured ICD-10 diagnosis E65 or E66 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Metabolic syndrome	At least three assured ICD-10 diagnoses out of five diagnoses groups (E66, E78.0, E78.1, I10, and E10-E14/R73), in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Previous malignant neoplasm	Documented malignant neoplasm (ICD-10 diagnosis C00-C97 excluding C44) in the Bavarian Cancer Registry	Previous to the NEN diagnosis for cases and matched controls
Primary	Alcohol buse	Assured ICD-10 diagnosis F10 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Diabetes	Assured ICD-10 diagnosis out of the diagnoses group E10-E14 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Ulcerative colitis	Assured ICD-10 diagnosis K51 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Crohn disease	Assured ICD-10 diagnosis K50 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Allergic rhinitis	Assured ICD-10 diagnosis J30.0 or J30.4 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Primary	Asthma	Assured ICD-10 diagnosis J45 in at least two out of four consecutive quarters	Two years previous to the NEN diagnosis for cases and matched controls
Secondary	Area deprivation	Area deprivation of the residence municipality (in quintiles) based on the Bavarian Index of Multiple Deprivation according to Maier, Fairburn & Mielck (2011, DOI: 10.1055/s-0031-1280846)	At the time of the NEN diagnosis for cases and matched controls