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Lysosomal Storage DiseasesNCT03812042

Screening of Lysosomal Storage Disorders Diseases in Minority Groups

An observational study of Lysosomal Storage Diseases, run by Lysosomal and Rare Disorders Research and Treatment Center, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim is to undertake a screening study that identifies undiagnosed patients with LSDs and determine the prevalence of these diseases with special focus on underrepresented minority groups. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Lysosomal Storage Diseases
What is being tested?
Enzyme assay and molecular sequencing
How many people
100,000 participants
Where
1 siteUnited States
Study dates
17 Mar 2016to Dec 2019
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study population will comprise of patients of healthcare institutions in the Washington, D.C. and Richmond, Virginia areas including but not limited to hospitals, clinics, and doctor's offices.

Who may be able to join

  • To be enrolled in this study the subject must meet the following (inclusion) criteria:
  • Subject is greater than or equal to 1 day of age and less than or equal to 100 years of age
  • Subject is managed by a physician in the Washington, D.C and Richmond, VA metro area
  • Subject is getting blood work as part of standard clinical care and there is at least 60 uL blood remained in a tube after all clinical tests were run

Who cannot join

  • subjects must not meet any of the following (exclusion) criteria:
  • Absolute contraindication for blood drawing
  • Subject cannot be traced back by the referring physician upon a positive screening result

Trial locations and contacts

1 site in 1 country.

United States1 site
  • LDRTC

    Fairfax, Virginia, 22030

Other trials in United States

About this study

Official title: Enzymatic and Genotypic Screening of Lysosomal Storage Diseases in Minority Groups

Aim is to undertake a screening study that identifies undiagnosed patients with LSDs and determine the prevalence of these diseases with special focus on underrepresented minority groups.

Read the detailed description

Lysosomes are small, cytoplasmic organelles that contain several acid hydrolase enzymes. These enzymes break down foreign materials and cellular debris allowing the lysosomes to act as recycling centers for the cells. Following DNA transcription, lysosomal enzymes are produced in the endoplasmic reticulum and targeted to lysosomes by specific recognition markers. If one of the enzymes is absent or if its function is diminished due to either an altered amino acid sequence of the protein or defective intracellular trafficking, the macromolecules metabolized by the specific enzyme will gradually accumulate in the lysosomes. Abnormal substrate storage leads to cellular dysfunction followed by cell death ultimately manifesting as tissue damage and organ failure.

More than 50 metabolic disorders resulting from defective lysosomal enzyme function have been described and are classified as lysosomal storage disorders (LSDs). Although individually uncommon (less than 1 in 100,000), the combined incidence of this group of genetic disorders is about 1 in 5,000 to 1 in 10,000. The prevalence might be even higher than predicted due to undiagnosed instances or misdiagnosis of milder cases.

Most of LSDs are inherited in an autosomal recessive manner except two disorders: Fabry disease and Hunter syndrome, which are X chromosome linked. Two healthy carriers of the same autosomal recessive disease may have an affected child. Usually the carriers are unaware of their carrier status prior to screening or until they have a sick child. These disorders are more common in communities with high consanguinity and where cousin marriages are allowed. In the case of X-linked diseases, the mutant gene is passed down from one generation to the next one in a specific way. If a male has an abnormal copy of the specific gene, he will show the typical presentation of the disease. If a woman has an abnormal copy of the specific gene, she may develop some milder symptoms of the disease due to random X- inactivation.

Screening for LSDs is performed by measuring enzymatic activity in peripheral blood. The most cost effective and convenient way is to use dried filter paper blood spots. A positive screening result has to be followed by a confirmatory enzymatic testing using white blood cells, plasma or cultured skin fibroblasts and/or DNA mutation analysis. The importance of screening for LSDs has been recognized by several state governments as these tests are being included in many newborn screening programs. Although newborn screening helps to identify patients early on, there is still an unmet need for population screening and for identifying patients with reversible tissue damage. LSDs cause serious and progressive problems with multiple body systems. Therapy is available and is promising in most cases. Importantly, patients with LSDs require thorough management plans for their complex health issues.

Being tested
Enzyme assay and molecular sequencing
Keywords
Gaucher disease, Fabry disease, Pompe disease, Gangliosidoses
Medical subject headings
Lysosomal Storage Diseases, Gaucher Disease, Fabry Disease, Glycogen Storage Disease Type II, Gangliosidoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enzyme assay and molecular sequencingDiagnostic test

    Enzyme assay and molecular sequencing on relevant samples conducted from left over blood samples

Study groups in NCT03812042
Study groupRoleWhat they receive
Screen populationThe study population will comprise of patients of healthcare institutions in the Washington, D.C. metro area including but not limited to hospitals, clinics, and doctor's offices.
Receives: Diagnostic Test: Enzyme assay and molecular sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enzyme activity analysis to identify subjects with Lysosomal storage disorders

    To identify patients with LSDs using enzymatic activity specific to individual lysosomal storage disorders using left-over blood of blood samples collected as part of standard clinical care.

    Measured: 5 years

  2. Genotypic analysis of subjects with abnormal enzyme activity

    Samples from subjects with abnormally low enzyme activity will be used for targeted sequencing analysis to diagnose any pathologic mutations.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start17 Mar 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
100,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812042
Sponsor's protocol ID
16-LDRTC-04
Status last verified
Jan 2019
First submitted
18 Jan 2019
Last updated
22 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Lysosomal Storage Diseases, run by Lysosomal and Rare Disorders Research and Treatment Center, Inc. at 1 site in United States.

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 3 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enzyme activity analysis to identify subjects with Lysosomal storage disorders (time frame: 5 years). The study lists 2 primary outcomes in all. 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 22 Jan 2019.

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