Myelodysplastic SyndromeNCT02060409
Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 17 to 90 years
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- spliceosome
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- therapy-related MDS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- spliceosome
- Keywords
- myelodysplastic syndrome, decitabine, spliceosome mutation
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spliceosomeGenetic
spliceosome mutations
| Study group | Role | What they receive |
|---|---|---|
| spliceosome | patient who have available data for spliceosome mutation status Receives: Genetic: spliceosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ho Jang, Samsung Medical Center
- Investigators
- Jun Ho Jang, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060409
- Sponsor's protocol ID
- 2012-01-081-003
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25964599
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Molecular Markers Determined by Using Gene Expression Profiling in Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02060409
- Acronym / sponsor ID
- 2012-01-081-003
- Conditions
- Myelodysplastic Syndrome
- Keywords
- myelodysplastic syndrome, decitabine, spliceosome mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spliceosome | – | Genetic: spliceosomepatient who have available data for spliceosome mutation status |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- therapy-related MDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spliceosomespliceosome mutations | Genetic | spliceosome |
Primary outcome
overall survival
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Derived from this study: PubMed 25964599Hong 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.
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Not yet recruitingPhase 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ho Jang, MD PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.