Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:

Prognostic Molecular Markers Determined by Using Gene Expression Profiling in Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060409
• Other study ID #: 2012-01-081-003
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 11, 2014
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Description:

A number of studies have tried to investigate clinical impact of mutations in spliceosomal machinery genes in MDS but they failed to demonstrate a consistent prognostic relevance. Moreover, the clinical impact of these mutations on the outcomes of hypomethylating agent treatment in MDS has never been explored yet. The investigators investigated the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 90 Years

Eligibility

Inclusion Criteria:

• de novo MDS patients were included in the study who had received 1st line decitabine treatment and had adequate genomic DNA from pretreated bone marrow samples

Exclusion Criteria:

• therapy-related MDS

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Genetic:
• spliceosome
spliceosome mutations

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Two years	No