Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Study Purpose

Neuroendocrine neoplasms (NEN) are rare tumors that mainly occur in the gastrointestinal tract and the lungs. The currently available diagnostic and prognostic markers do not adequately represent the diversity of these tumors. Methylation analyzes of the tumor DNA represent a new, promising approach. The aim of this project is therefore to improve the diagnostic and prognostic evaluation of neuroendocrine neoplasms by means of methylation analysis of the tumor DNA. On the one hand, existing tumor samples from the biobank of Basel University Hospital are evaluated, on the other hand, patients who are undergoing an operation will be prospectively inquired

Recruitment Criteria

Accepts Healthy Volunteers

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

No
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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - neuroendocrine tumor.

Exclusion Criteria:

- insufficient amount or quality of neuroendocrine tumor sample

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.

NCT05013957
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.

University Hospital, Basel, Switzerland
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Other
Overall Status Enrolling by invitation
Countries Switzerland
Conditions

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

Neuroendocrine Tumors
Arms & Interventions

Arms

: Retrospective analysis

Methylome of existing neuroendocrine tumor samples from the biobank of Basel University Hospital will be evaluated

: Prospective analysis

Methylome analysis of tumor samples of neuroendocrine tumor patients undergoing an operation or biopsy will be prospectively evaluated

Interventions

Diagnostic Test: - Methylation analysis

Methylation analysis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Basel, Basel Stadt, Switzerland

Status

Address

University Hospital Basel, Department of Endocrinology

Basel, Basel Stadt, 4031

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