MS Detection of Somatic Mutations in Hematological Malignancies

NCT03771079 | Unknown

• 1 other identifier: 7259
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Hematological Malignancy

Keywords

Hematological Malignancy; mutations; NGS sequencing; mass spectrometry

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

anonymized samples from patients already studied with NGS in Strasbourg university hematology center for somatic mutations

You may qualify if:

• 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

You may not qualify if:

• opposition for testing the archive sample with the new method
• insufficient archival material
• patient under protection

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Laboratoire d'Hématologie

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Laurent MAUVIEUX, MD, PhD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent MAUVIEUX, MD, PhD

CONTACT

33 3 88 12 75 27; laurent.mauvieux@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 10, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

FR (1)