NCT02401932

Brief Summary

Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

March 9, 2015

Last Update Submit

November 8, 2015

Conditions

Hemophagocytosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    12 Months

Study Arms (1)

Hemophagocytosis

The group includes patients who have the evidence of hemophagocytosis in their bone marrow or other sites.

Other: Hemophagocytosis

Interventions

HemophagocytosisOTHER

Best supportive care and immunosuppressive treatments

Hemophagocytosis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy

You may not qualify if:

  • patients who did not evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

  • Seok Jin Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 30, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

KR(1)