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

Completed

• Conditions: Cancer
• Interventions: Procedure: Bone marrow aspiration

• Registration Number: NCT00706199
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Study Start: 2008-07-03
• Primary Completion: 2009-01-23
• Study Completion: 2009-01-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Bone marrow aspiration	donors

Primary Outcome Measures

Name	Time	Method
Number of copies of PRAME (Preferentially expressed in melanoma)antigen expression in bone marrow	At Day 0	Establishment of the range of PRAME transcript levels in a collection of bone marrow samples by real-time quantitative RT-PCR (Reverse Transcription Polymerase Chain Reaction). Due to the low numbers, they were expressed as \[value x 10E-03\]. Only the samples with gene expression \>0 were presented.
Number of copies of Wilms' Tumor 1 (WT1) antigen expression in bone marrow	At Day 0	Establishment of the range of WT1 transcript levels in a collection of bone marrow samples by real-time quantitative RT-PCR (Reverse Transcription Polymerase Chain Reaction). Due to the low numbers, they were expressed as \[value x 10E-03\]. Only the samples with gene expression \>0 were presented.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Ottignies, Belgium