Myelodysplastic SyndromeNCT02330692
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Sep 2023
- How long will I take part?
- 10 Years
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are diagnosed with MDS in Severance Hospital. All patients are eligible for study occuring from the starting day of the study. Patients are enrolled if the written consent are acquired. Considering the annual incidence rate of the disease, target patient population is 1,000 people during the study period.
Who may be able to join
- MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.
- Male and Female over 16 years of age. ③ Written consent of the patient to participate in the cohort ④ Deaths during the study period are waiver of consent
Who cannot join
- ① Refusal or trouble understanding the written consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Joon-Won Cheong, MD, Ph.D, 82-2-2228-1970
About this study
Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- No intervention
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients with MDS to examine new prognostic factors
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330692
- Sponsor's protocol ID
- 4-2013-0479
- Status last verified
- Jan 2019
- First submitted
- 25 Dec 2014
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02330692
- Acronym / sponsor ID
- 4-2013-0479
- Conditions
- Myelodysplastic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Jan 2015 (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.
Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are diagnosed with MDS in Severance Hospital. All patients are eligible for study occuring from the starting day of the study. Patients are enrolled if the written consent are acquired. Considering the annual incidence rate of the disease, target patient population is 1,000 people during the study period.
Key inclusion criteria (2 listed)
- MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.
Key exclusion criteria (1 listed)
- ① Refusal or trouble understanding the written consent
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
the number of patients with MDS to examine new prognostic factors
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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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.
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 Yonsei University 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 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients with MDS to examine new prognostic factors (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.