Ocular Graft Versus Host Disease After Hematopoietic Stem... | NCT00912067

Studies
Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults

NCT00912067

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 3, 2009Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Graft Versus Host Disease

Interventions

Not provided

Countries

Israel

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 1, 2009

First Posted Date

Jun 3, 2009Estimated

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

Jun 1, 2009

Last Update Posted Date

Jun 3, 2009Estimated

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

The purpose of this study is to evaluate the presence and manifestations of ocular graft versus host disease in adults that had hematopoietic stem cell transplantation in the past 3 years at the sheba medical center, Israel. As well as correlate the degree of the presentation to the therapeutic protocol (chemotherapy and irradiation).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

120Estimated

Label	Type	Description	Intervention Names
hematopoietic stem cell transplantation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

after hematopoietic stem cell transplantation done at sheba medical center Israel
3 month have past from transplantation but no more then 3 years

Exclusion Criteria:

transplantation done in the last 3 month or more than 3 years have past since

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults after hematopoietic stem cell transplantation done at sheba medical center Israel during the last 3 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
irina barequet, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16900025	Background	Kim SK. Update on ocular graft versus host disease. Curr Opin Ophthalmol. 2006 Aug;17(4):344-8. doi: 10.1097/01.icu.0000233952.09595.d8.
15523196	Background	Anderson NG, Regillo C. Ocular manifestations of graft versus host disease. Curr Opin Ophthalmol. 2004 Dec;15(6):503-7. doi: 10.1097/01.icu.0000143684.22362.46.