Risk Factors for Neuroendocrine Neoplasms

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Resident in Bavaria for the years 2020 and 2021.

Exclusion Criteria:

- None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06282016
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bavarian Cancer Registry
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jacqueline Müller-NordhornMartin Tauscher
Principal Investigator Affiliation Bavarian Cancer Registry, Bavarian Health and Food Safety AuthorityBavarian Association of Statutory Health Insurance Accredited Physicians
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Neoplasm of Lung, Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder)
Arms & Interventions

Arms

: Cases

Patients with a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed in the years 2020 or 2021

: Controls

Patients without a neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system diagnosed in the years 2020 or 2021 (=no documented diagnosis of neuroendocrine neoplasm of the bronchopulmonary or gastroenteropancreatic system in the Bavarian Cancer Registry)

Interventions

Other: - Case-control study (no intervention)

Observation of risk factors in cases and controls

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Sven Voigtländer

sven.voigtlaender@lgl.bayern.de

+49-(0)9131-6808

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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