- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03771079
MS Detection of Somatic Mutations in Hematological Malignancies (MAHM)
Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies
Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.
The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laurent MAUVIEUX, MD, PhD
- Phone Number: 33 3 88 12 75 27
- Email: laurent.mauvieux@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67098
- Recruiting
- Laboratoire d'Hématologie
-
Contact:
- Laurent MAUVIEUX, MD, PhD
- Phone Number: 33 3 88 12 75 27
- Email: laurent.mauvieux@chru-strasbourg.fr
-
Contact:
- Laurent MIGUET, MD
- Phone Number: 33 3 88 12 75 27
- Email: Laurentyannick.miguet@chru-strasbourg.fr
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Principal Investigator:
- Laurent MAUVIEUX, MD, PhD
-
Sub-Investigator:
- Laurent MIGUET, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults >18 years old
- anonymized samples already studied with NGS in Strasbourg university hematology center for somatic mutations
- non-opposition of the patient for testing the archive sample with the new method
Exclusion Criteria:
- opposition for testing the archive sample with the new method
- insufficient archival material
- patient under protection
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)
Time Frame: 10 months
|
Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing.
This powerful approach is nevertheless time consuming and its costs represent limitation for its availability.
An original approach is now available, using mass spectrometry (MS).
In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.
|
10 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurent MAUVIEUX, MD, PhD, University Hospital, Strasbourg, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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