Genetic DiseaseMetaPrintNCT05305729
Metabolic FingerPrinting
An observational study of Genetic Disease, run by Arcensus GmbH at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Genetic Disease
- How many people
- 10,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Mar 2021to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All subjects with a confirmed genetic disease as well as their first degree family members can participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Pakistan4 sites, 4 recruiting
- Recruiting
Pakistan Institute of Medical Sciences (PIMS)
Islamabad, 4485
Maqbool Hussain, Prof.
- Recruiting
The Children's hospital & Institute of child health
Lahore, Punjab Province, 54000
Huma Cheema, Prof.
- Recruiting
Children's Hospital & The Institute of Child Health
Multan, 60000
Nuzhat Rana, Prof.
- Recruiting
Khyber institute of Child Health and Children Hospital (KICH)
Peshawar, 25100
Khalil Rehman, Dr.
Albania1 site, 1 recruiting
- Recruiting
University Hospital Center Mother Teresa
Tirana, 1000
Paskal Cullufi, Prof.
About this study
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.
- Conditions
- Genetic Disease
- Being tested
- No intervention
- Keywords
- Metabolic Fingerprint
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Subjects with a genetic disease | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Mar 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcensus GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305729
- Sponsor's protocol ID
- MetaPrint-2021
- Acronym
- MetaPrint
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of IPDs can be discussed after receiving scientific requests.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic FingerPrinting
- ClinicalTrials.gov ID
- NCT05305729
- Acronym / sponsor ID
- MetaPrint / MetaPrint-2021
- Conditions
- Genetic Disease
- Keywords
- Metabolic Fingerprint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Arcensus GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with a genetic disease | – | Other: No intervention |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects with a confirmed genetic disease as well as their first degree family members can participate in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Subjects with a genetic disease |
Primary outcome
Number of newly identified, disease-specific Metabolic Fingerprints
Time frame: 5 years
Plasma-derived metabolite profiles that are specific for a particular genetic disease in comparison to healthy controls and other genetic diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided. Sharing of IPDs can be discussed after receiving scientific requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Disease, run by Arcensus GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Pakistan, Albania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volha Skrahina, PhD (+49 172 4182235, volha.skrahina@arcensus-diagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of newly identified, disease-specific Metabolic Fingerprints (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.