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Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT02060409
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Jun Ho Jang, Samsung Medical Center

Brief 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.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Genetic: spliceosome

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.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prognostic Molecular Markers Determined by Using Gene Expression Profiling in Patients With Myelodysplastic Syndrome
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. overall survival [ Time Frame: Two years ]

Biospecimen Retention:   Samples With DNA
Genomic DNA extracted from bone marrow aspirate


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060409


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jun Ho Jang, MD PhD Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Ho Jang, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02060409     History of Changes
Other Study ID Numbers: 2012-01-081-003
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Jun Ho Jang, Samsung Medical Center:
myelodysplastic syndrome
decitabine
spliceosome mutation

Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms