NCT05305729

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.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
recruiting

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

Study Start

First participant enrolled

March 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

March 21, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

Metabolic Fingerprint

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Subjects with a genetic disease

Other: No intervention

Interventions

No intervention

Subjects with a genetic disease

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Center Mother Teresa

Tirana, 1000, Albania

RECRUITING

The Children's hospital & Institute of child health

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Pakistan Institute of Medical Sciences (PIMS)

Islamabad, 4485, Pakistan

RECRUITING

Children's Hospital & The Institute of Child Health

Multan, 60000, Pakistan

RECRUITING

Khyber institute of Child Health and Children Hospital (KICH)

Peshawar, 25100, Pakistan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from all participants.

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

March 1, 2021

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations