MS Detection of Somatic Mutations in Hematological Malignancies

• Conditions: Hematological Malignancy

• Registration Number: NCT03771079
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-01
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)	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.

Trial Locations

Locations (1)

Laboratoire d'Hématologie; 🇫🇷 Strasbourg, France