MS Detection of Somatic Mutations in Hematological Malignancies

Hematological Malignancy Clinical Trial

— MAHM  

Official title:

Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771079
• Other study ID #: 7259
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: University Hospital, Strasbourg, France
• Contact: Laurent MAUVIEUX, MD, PhD
• Phone: 33 3 88 12 75 27
• Email: laurent.mauvieux[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematological Malignancy
• Neoplasms

Locations

Country	Name	City	State
France	Laboratoire d'Hématologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)	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