HemophagocytosisNCT02401932
Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow
An observational study of Hemophagocytosis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemophagocytosis
- What is being tested?
- Hemophagocytosis
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Sep 2015
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators reviewed the electronic data base of medical records at the Samsung Medical Center, and selected 264 patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy between January 2000 and June 2014.
Who may be able to join
- patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy
Who cannot join
- patients who did not evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Malignant and Non-malignant Disorders Associated Bone Marrow Hemophagocytosis: A Single Center Experience
Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.
Read the detailed description
This is a retrospective study comparing malignant and non-malignant disorders associated bone marrow hemophagocytosis. The medical record of patients who had documented evidences of hemophagocytosis in bone marrow are reviewed. The clinical and biological characteristics are compared according to the underlying disorders of hemophagocytosis.
- Conditions
- Hemophagocytosis
- Being tested
- Hemophagocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemophagocytosisOther
Best supportive care and immunosuppressive treatments
| Study group | Role | What they receive |
|---|---|---|
| Hemophagocytosis | The group includes patients who have the evidence of hemophagocytosis in their bone marrow or other sites. Receives: Other: Hemophagocytosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophagocytosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Jin Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401932
- Sponsor's protocol ID
- 2015-02-013
- Status last verified
- Nov 2015
- First submitted
- 9 Mar 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Malignant and Non-malignant Disorders Associated Bone Marrow Hemophagocytosis: A Single Center Experience
- ClinicalTrials.gov ID
- NCT02401932
- Acronym / sponsor ID
- 2015-02-013
- Conditions
- Hemophagocytosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Mar 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.
Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.
Detailed description
This is a retrospective study comparing malignant and non-malignant disorders associated bone marrow hemophagocytosis. The medical record of patients who had documented evidences of hemophagocytosis in bone marrow are reviewed. The clinical and biological characteristics are compared according to the underlying disorders of hemophagocytosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophagocytosis | – | Other: HemophagocytosisThe group includes patients who have the evidence of hemophagocytosis in their bone marrow or other sites. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators reviewed the electronic data base of medical records at the Samsung Medical Center, and selected 264 patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy between January 2000 and June 2014.
Key inclusion criteria (1 listed)
- patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy
Key exclusion criteria (1 listed)
- patients who did not evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy
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 |
|---|---|---|
| HemophagocytosisBest supportive care and immunosuppressive treatments | Other | Hemophagocytosis |
Primary outcome
Overall survival
Time frame: 12 Months
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 10 Nov 2015.
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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.
Seok Jin Kim, 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 Hemophagocytosis, 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 10 Nov 2015. 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: 12 Months). 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 10 Nov 2015.