The Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
February 1, 2018 updated by: GlaxoSmithKline
Analysis of Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ottignies, Belgium, 1340
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
donors
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Collection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of copies of Wilms' Tumor 1 (WT1) antigen expression in bone marrow
Time Frame: 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.
|
At Day 0
|
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Number of copies of PRAME (Preferentially expressed in melanoma)antigen expression in bone marrow
Time Frame: 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.
|
At Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 3, 2008
Primary Completion (Actual)
January 23, 2009
Study Completion (Actual)
January 23, 2009
Study Registration Dates
First Submitted
June 25, 2008
First Submitted That Met QC Criteria
June 26, 2008
First Posted (Estimate)
June 27, 2008
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
February 1, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 111684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.