The Expression of Antigens in Bone Marrow Samples From Volunteering Donors.

This study is currently recruiting participants.

Verified by GlaxoSmithKline, October 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00706199

Purpose

Antigen expression levels in bone marrow from volunteering donors will be analyzed. The results of this analysis will be used to establish a clinical test to identify cancer patients who could qualify to receive an investigational treatment being developed by GlaxoSmithKline.

Condition	Intervention
Antigen Expression in Bone Marrow From Donors	Procedure: Bone marrow aspiration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Open Label, Single Group Assignment
Official Title:	Analysis of Expression of Antigens in Bone Marrow Samples From Volunteering Donors.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Levels of antigen expression in bone marrow [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A donors	Procedure: Bone marrow aspiration Collection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The donor is aged >= 18 years
Written informed consent has been obtained prior to the performance of any specific procedure.
The donor has a medical indication for which a bone marrow aspiration is planned.
The donor is eligible for a bone marrow aspiration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706199

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Belgium
GSK Investigational Site	Recruiting
Ottignies, Belgium, 1340

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111684
Study First Received:	June 25, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00706199
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

bone marrow
volunteers
antigen expression

ClinicalTrials.gov processed this record on January 16, 2009