Place of the Hevylite Test in the Evaluation of MRD in Myeloma
NCT ID: NCT03702088
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
124 participants
OBSERVATIONAL
2018-10-01
2020-12-30
Brief Summary
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Detailed Description
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Two techniques currently prevail in the evaluation of minimal residual disease: high throughput sequencing (NGS) and multi-parameter flow cytometry. They are included in evaluation criteria defined by the International Myeloma Working Group (IMWG). These techniques have the advantage of being very sensitive, reaching 10-5 (cytometry: 50 events among 5 000 000 cells analysed) to 10-6 (NGS). Nevertheless, they are invasive for the patient (medullary specimen), require technical expertise and are not necessarily available in all hospitals.
The development of blood tests would cope with this constraints.
The Hevylite® assay is a simple, sensitive, automated and inexpensive immunologic technique that allows the accurate quantification of total IgG, Total IgG, Total IgA, Total IgA L, Total IgM, and Total IgM in the blood. Given its characteristics, the Hevylite assay could play a role in the definition of MRD and allow evaluation of residual disease in myeloma.
This study aims to evaluate the positive predictive value of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
\- Any number of treatment lines received
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Hospices Civils de Lyon
OTHER
CLB de Lyon
UNKNOWN
Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Laure Vincent, Md
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL18_0234
Identifier Type: -
Identifier Source: org_study_id
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