NCT05013957

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 29, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

August 17, 2021

Last Update Submit

January 27, 2025

Conditions

Neuroendocrine Tumors

Keywords

Methyloma

Outcome Measures

Primary Outcomes (1)

  • Methylation-based classification of NEN samples

    NEN samples will be classified according to methylation analysis

    3 years

Study Arms (2)

Retrospective analysis

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

Diagnostic Test: Methylation analysis

Prospective analysis

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

Diagnostic Test: Methylation analysis

Interventions

Methylation analysisDIAGNOSTIC_TEST

Methylation analysis

Prospective analysisRetrospective analysis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neuorendocrine tumor patients

You may qualify if:

  • neuroendocrine tumor

You may not qualify if:

  • insufficient amount or quality of neuroendocrine tumor sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 20, 2021

Study Start

January 1, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 29, 2025

Record last verified: 2024-12

Locations

CH(1)