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Acid Lipase DeficiencyBioWolmanNCT02383641

Biomarker for Wolman Disease (BioWolman)

An observational study of Acid Lipase Deficiency and Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type, run by CENTOGENE GmbH Rostock at 3 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease blood (plasma) Read more about this study

Who is it for?
Ages 2 months and older
How many people
0 participants
Where
3 sitesin 3 countries
Study dates
20 Aug 2018to 28 Feb 2021
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: Patients with Wolman disease or high-grade suspicion for Wolman disease

Who may be able to join

  • Informed consent will be obtained from the parents before any study related procedures.
  • Patients of both gender older than 2 month
  • The patient has a diagnosis of Wolman disease or a high-grade suspicion for Wolman disease
  • High-grade suspicion present, if one or more inclusion criteria are valid:
  • Positive family anamnesis for Wolman disease
  • Vomiting, diarrhea
Show all 11Show fewer
  • Malnourishment, difficulty growing and gaining weight
  • Enlarged liver and spleen (hepatosplenomegaly), which causes a distended abdomen
  • Low muscle tone (hypotonia)
  • Anemia
  • x-ray reveals calcified adrenal glands

Who cannot join

  • No Informed consent from the parents before any study related procedures.
  • Patients of both gender younger than 2 month
  • No diagnosis of Wolman disease or no valid criteria for profound suspicion of Wolman disease

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Germany1 site
  • Centogene AG

    Rostock, 18055

Other trials in Germany

India1 site
  • Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)

    Mumbai, 400705

Other trials in India

Sri Lanka1 site
  • Lady Ridgeway Hospital for Children

    Colombo, 00800c

Other trials in Sri Lanka

About this study

Official title: Biomarker for Wolman Disease, AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL

Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease blood (plasma)

Read the detailed description

Wolman disease (WD) is a rare genetic disorder characterized by complete absence of an enzyme known as lysosomal acid lipase (LIPA). This enzyme is required to breakdown (metabolize) lipids in the body. Without the LIPA enzyme, lipids may abnormally accumulate in the tissues and organs of the body causing a variety of symptoms.

WD is the most severe expression of LIPA deficiency. Milder form of the disorder are known as cholesteryl ester storage deficiency. The symptoms of WD usually become apparent shortly after birth, usually during the first few weeks of life. Affected infants may develop bloating or abdominal distention and may have significant hepatosplenomegaly. Fibrosis of the liver may also occur. In some cases, fluid may accumulate in the abdominal cavity (ascites). Infants with WD have serious digestive abnormalities including malabsorption, a condition in which the intestines fail to absorb nutrients and calories from food. Malabsorption associated with WD causes persistent and often forceful vomiting, frequent diarrhea, foul-smelling, fatty stools (steatorrhea) and malnutrition. Because of these digestive complications, affected infants usually fail to grow and gain weight at the expected rate for their age and sex (failure to thrive).

Hepatosplenomegaly and protrusion of the abdomen can cause umbilical hernia, a condition in which the contents of the stomach may push through an abnormal opening or tear in the abdominal wall near the bellybutton. Additional symptoms may also occur in WD including yellowing of the skin, mucous membranes and whites of the eyes (jaundice), a persistent low-grade fever, and poor muscle tone (hypotonia). Infants may exhibit delays in the development of motor skills.

A distinct finding associated with WD is the hardening of adrenal gland tissue due to the accumulation of calcium (calcification). The adrenal glands are located on top of the kidneys and produce epinephrine and norepinephrine. Other hormones produced by the adrenal glands help to regulate the fluid and electrolyte balance in the body. Calcification of the adrenal glands is not detectable by physical examination, but can be seen with x-ray study. Calcification may prevent the adrenal glands from producing enough essential hormones and can affect metabolism, blood pressure, the immune system and other vital processes of the body.

Infants with WD may experience the loss of previously acquired skills required the coordination of muscle and motor skills (psychomotor regression). The symptoms of WD often get progressively worse eventually leading to life-threatening complications during infancy including extremely low levels of circulating red blood cells (severe anemia), hepatic dysfunction or failure, and physical wasting away and severe weakness often associated with chronic disease and marked by weight loss and loss of muscle mass (cachexia or inanition).

WD is caused by mutations of the lysosomal acid lipase (LIPA) gene. It is inherited as an autosomal recessive trait. More than 50 cases have been reported in the medical literature. However, cases may go undiagnosed or misdiagnosed making it difficult to determine the disorder's true frequency in the general population.

New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood (plasma) of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity.

Therefore it is the goal of the study to identify and validate a new biochemical marker from the plasma of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.

Keywords
Wolman disease, Biomarker
Medical subject headings
Wolman Disease, Cholesterol Ester Storage Disease

What participants receive

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

Study groups in NCT02383641
Study groupRoleWhat they receive
ObservationPatients with Wolman disease or high-grade suspicion for Wolman disease

What is being measured

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

  1. Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease from blood

    New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity.

    Measured: 24 months

Secondary outcomes (1)
  1. Testing for clinical robustness, specificity and long-term stability of the biomarker

    the goal of the study to identify and validate a new biochemical marker from the blood of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.

    Measured: 36 month

Timeline

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

  1. First posted9 Mar 2015 (estimated)
  2. Study start20 Aug 2018
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Why it stopped: Transition to BioMetabol

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
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02383641
Sponsor's protocol ID
BWD 06-2018
Acronym
BioWolman
Status last verified
Feb 2023
First submitted
3 Mar 2015
Last updated
13 Feb 2023
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 Acid Lipase Deficiency and Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type, run by CENTOGENE GmbH Rostock at 3 sites in 3 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 11 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: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, India, Sri Lanka. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease from blood (time frame: 24 months). 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 13 Feb 2023.

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