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NCT05013957 Clinical Trial

Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Neuroendocrine Tumors Clinical Trial

— NEMESIs  

Official title:
Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05013957
Other study ID # NEMESIs study
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2031

Study information
Verified date May 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 31, 2031
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - neuroendocrine tumor Exclusion Criteria: - insufficient amount or quality of neuroendocrine tumor sample

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Methylation analysis
Methylation analysis

Locations
Country Name City State
Switzerland University Hospital Basel, Department of Endocrinology Basel Basel Stadt

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Methylation-based classification of NEN samples NEN samples will be classified according to methylation analysis 3 years
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