WithdrawnNot Applicable

Biomarker for Gangliosidosis: BioGM1/BioGM2 (BioGM1/GM2)

Stopped: Transition to BioMetabol

Egypt, Germany, India0Started 2018-08-20

Plain-language summary

Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of GM1/GM2 from blood

Who can participate

Age range2 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: * Informed consent will be obtained from the parents before any study related procedures. * Patients of both genders aged 2 months and older * The patient has a diagnosis of GM1/GM2-Gangliosidosis or a high-grade suspicion for GM1/GM2-Gangliosidosis * High-grade suspicion for GM1 or GM2 present, if one or more inclusion criteria are valid: Positive family anamnesis for GM1 or GM2 disease Neurodegenerative symptoms Skeletal symptoms Cherry Red Spot EXCLUSION CRITERIA: * No Informed consent from the parents before any study related procedures. * No diagnosis of GM1/GM2 disease or no valid criteria for profound suspicion of GM1/GM2 -disease * Patients of both genders younger than 2 months

What they're measuring

Development of a new MS-based biomarker for the early and sensitive diagnosis of GM1/GM2-Gangliosidosis from blood

Timeframe: 24 months

Trial details

NCT IDNCT02298647

SponsorCENTOGENE GmbH Rostock

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-02-28

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