Retrospective Analysis for Patients With Hemophagocytosis... | NCT02401932

Studies
Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow

NCT02401932

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Nov 10, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Hemophagocytosis

Interventions

Hemophagocytosis

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 24, 2015

First Posted Date

Mar 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2015

Last Update Posted Date

Nov 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemophagocytosis		The group includes patients who have the evidence of hemophagocytosis in their bone marrow or other sites.	Other: Hemophagocytosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemophagocytosis	Other	Best supportive care and immunosuppressive treatments	Hemophagocytosis

Measure	Description	Time Frame
Overall survival		12 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seok Jin Kim, MD, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea