MedDataX Logo

MS Detection of Somatic Mutations in Hematological Malignancies

NCT ID: NCT03771079

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematological Malignancy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hematological Malignancy mutations NGS sequencing mass spectrometry

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent MAUVIEUX, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laboratoire d'Hématologie

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laurent MAUVIEUX, MD, PhD

Role: CONTACT

Phone: 33 3 88 12 75 27

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laurent MAUVIEUX, MD, PhD

Role: primary

Laurent MIGUET, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7259

Identifier Type: -

Identifier Source: org_study_id