Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome

February 11, 2014 updated by: Jun Ho Jang, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
spliceosome
patient who have available data for spliceosome mutation status
Genetic: spliceosome
spliceosome mutations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jun Ho Jang, MD PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-01-081-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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