Metabolic FingerPrinting | NCT05305729

Studies
Metabolic FingerPrinting

NCT05305729

Sponsor

Arcensus GmbH

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Genetic Disease

Interventions

No intervention

Countries

Albania
Pakistan

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Mar 21, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Mar 31, 2022Actual

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

Mar 30, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The MetaPrint study aims to characterize the metabolic fingerprint of genetic diseases in order to enhance knowledge on the physiological disease status and establish so new tools for diagnosing, monitoring and personalizing treatment of genetic diseases.

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

Retention

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with a genetic disease			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Subjects with a genetic disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of newly identified, disease-specific Metabolic Fingerprints	Plasma-derived metabolite profiles that are specific for a particular genetic disease in comparison to healthy controls and other genetic diseases	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent is obtained from the participant or from the parent/ legal guardian
The participant is 2 months or older
The participant is diagnosed with a genetic disease
The participant is a first degree relative of a subject diagnosed with a genetic disease

Exclusion Criteria:

Informed consent is not obtained from the participant or from the parent/ legal guardian
The participant is younger than 2 months
The participant is not diagnosed with a genetic disease
The participant is not a first degree relative of a subject diagnosed with a genetic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All subjects with a confirmed genetic disease as well as their first degree family members can participate in the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Volha Skrahina, PhD	Contact	+49 172 4182235		volha.skrahina@arcensus-diagnostics.com
Arndt Rolfs, Prof. Dr.	Contact	+49 171 4710484		arndt.rolfs@arcensus-diagnostics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Center Mother Teresa	Recruiting	Tirana		1000	Albania

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Sharing of IPDs can be discussed after receiving scientific requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 3, 2025
Reset	Jul 22, 2025

Submission Tracking

Estimated Results First Submitted Date

Jul 3, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 3, 2025			Jul 22, 2025

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided