Neuroendocrine Neoplasms Methylation Based Classifier - T... | NCT05013957

Studies
Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

NCT05013957

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jan 29, 2025Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Neuroendocrine Tumors

Interventions

Methylation analysis

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Aug 17, 2021

First Submission Date that Met QC Criteria

Aug 17, 2021

First Posted Date

Aug 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Jan 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Methylation analysis	Diagnostic Test	Methylation analysis	Prospective analysis Retrospective analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methylation-based classification of NEN samples	NEN samples will be classified according to methylation analysis	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neuroendocrine tumor

Exclusion Criteria:

insufficient amount or quality of neuroendocrine tumor sample

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Neuorendocrine tumor patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel, Department of Endocrinology		Basel	Canton of Basel-City	4031	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided