NCT02060409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

February 10, 2014

Last Update Submit

February 11, 2014

Conditions

Myelodysplastic Syndrome

Keywords

myelodysplastic syndromedecitabinespliceosome mutation

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Two years

Study Arms (1)

spliceosome

patient who have available data for spliceosome mutation status

Genetic: spliceosome

Interventions

spliceosomeGENETIC

spliceosome mutations

spliceosome

Eligibility Criteria

Age17 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • therapy-related MDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Hong JY, Seo JY, Kim SH, Jung HA, Park S, Kim K, Jung CW, Kim JS, Park JS, Kim HJ, Jang JH. Mutations in the Spliceosomal Machinery Genes SRSF2, U2AF1, and ZRSR2 and Response to Decitabine in Myelodysplastic Syndrome. Anticancer Res. 2015 May;35(5):3081-9.

    PMID: 25964599DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA extracted from bone marrow aspirate

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jun Ho Jang, MD PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jun Ho Jang

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 12, 2014

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

February 1, 2014

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

KR(1)