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.
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
- Conditions the study is for
- Acid Lipase Deficiency, Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type, Cholesterol Ester Storage Disease
- 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
India1 site
Navi Mumbai Institute of Research In Mental And Neurological Handicap (NIRMAN)
Mumbai, 400705
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.
- Conditions
- Acid Lipase Deficiency, Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type, Cholesterol Ester Storage Disease
- 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 group | Role | What they receive |
|---|---|---|
| Observation | Patients 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.
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)
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.
- First posted9 Mar 2015 (estimated)
- Study start20 Aug 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Transition to BioMetabol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Lipase DeficiencyStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bauer, Prof., Study chair, Centogene GmbH
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Wolman Disease, AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
- ClinicalTrials.gov ID
- NCT02383641
- Acronym / sponsor ID
- BioWolman / BWD 06-2018
- Conditions
- Acid Lipase Deficiency, Acid Cholesteryl Ester Hydrolase Deficiency, Wolman Type, Cholesterol Ester Storage Disease
- Keywords
- Wolman disease, Biomarker
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Transition to BioMetabol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 9 Mar 2015 (estimated)
- 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.
Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease blood (plasma)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with Wolman disease or high-grade suspicion for Wolman disease |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Wolman disease or high-grade suspicion for Wolman disease
Key inclusion criteria (11 listed)
- 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
- Positive family anamnesis for Wolman disease
- Vomiting, diarrhea
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman disease from blood
Time frame: 24 months
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.
1 secondary outcome
Testing for clinical robustness, specificity and long-term stability of the biomarker
Time frame: 36 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Centogene is one of the leading laboratories focusing on genetic testing for rare hereditary disorders. We now offer more than 2200 routine genetic and biochemical tests.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Peter Bauer, Prof. study chair
Centogene GmbH
3 sites in 3 countries: see every site and its status.
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.