ClinicalTrials.gg
Status unknownNCT02045654Updated Jan 27, 2014

Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

An observational study in Myelodysplastic Syndrome, sponsored by Samsung Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-27.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study summary

To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

Read the detailed description
  • Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications
  • Survival and response Analysis
  • Response rate
  • Overall survival
  • Leukemia free survival
02

Conditions studied

  • Myelodysplastic Syndrome
03

In context

Myelodysplastic Syndromes

2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.

This study's planned enrollment of 1 is below the median of 146 across 219 observational studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

Eligibility criteria

Inclusion Criteria:

  • Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1 participant (estimated)
Patient registry
No

Groups and cohorts

  • MDS patients

    MDS patients who were treated with decitabine

06

What researchers measure

Primary outcomes

  1. Response rate

    International Working Group (IWG) response criteria

    Time frame: 1 year

Secondary outcomes

  1. Overall survival

    measured from the date of decitabine therapy to the date of death or the last follow-up visit

    Time frame: 1 year

  2. Leukemia free survival

    the date of decitabine therapy to the date of death or leukemic transformation

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Division of Hematology Oncology, Samsung Medical Center
    Seoul, 135-710, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Feb 2014 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2014
First posted
Jan 27, 2014
Start
Jan 2014
Primary completionEst.
Feb 2014
CompletionEst.
Mar 2015
Last update
Jan 27, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02045654
Responsible party
Jun Ho Jang (Professor, Samsung Medical Center) — Principal investigator
First posted
Jan 27, 2014
Start date
Jan 2014
Primary completion
Feb 2014 (estimated)
Completion
Mar 2015 (estimated)
Last update
Jan 27, 2014

Study contacts

Jun Ho Jang, Pf
Contact
jh21.jang@samsung.com
Jun Ho Jang, Pf
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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