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Trial Title: Risk Factors for Neuroendocrine Neoplasms

NCT ID: NCT06282016

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

Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Lung Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms

Conditions: Keywords:
Neuroendocrine neoplasms
Colorectal cancer
Risk factors
Case-Control Study
Cancer Registry

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Other
Intervention name: Case-control study (no intervention)
Description: Observation of risk factors in cases and controls
Arm group label: Cases
Arm group label: Controls

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.

Criteria for eligibility:

Study pop:
Cases are defined as all persons with a malignant neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed in 2020 or 2021. 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 in 2020 or 2021, whose residence was in Bavaria. Two controls will be sampled for each case.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Persons with a statutory health insurance (about 85% of the population) and at least one outpatient physician contact in Bavaria in 2020 or 2021 - Residence in Bavaria Exclusion Criteria: - None

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: October 15, 2024

Completion date: August 2025

Lead sponsor:
Agency: Bavarian Cancer Registry
Agency class: Other

Collaborator:
Agency: Bavarian Association of Statutory Health Insurance Accredited Physicians
Agency class: Other

Source: Bavarian Cancer Registry

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06282016

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