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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706199
• Other study ID #: 111684
• Status: Completed
• Phase: N/A
• First received: June 25, 2008
• Last updated: February 1, 2018
• Start date: July 3, 2008
• Est. completion date: January 23, 2009

Study information

• Verified date: February 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 23, 2009
• Est. primary completion date: January 23, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Bone marrow aspiration
Collection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Ottignies

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of copies of Wilms' Tumor 1 (WT1) antigen expression in bone marrow	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.	At Day 0
Primary	Number of copies of PRAME (Preferentially expressed in melanoma)antigen expression in bone marrow	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.	At Day 0