CancerNCT00706199
The Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
An observational study of Cancer, run by GlaxoSmithKline at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Bone marrow aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jul 2008to 23 Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Bone marrow aspiration
- Keywords
- bone marrow, antigen expression, volunteers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirationProcedure or surgery
Collection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes.
| Study group | Role | What they receive |
|---|---|---|
| Group A | donors Receives: Procedure: Bone marrow aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 0
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.
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study start3 Jul 2008
- Primary completion23 Jan 2009
- Study completion23 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706199
- Sponsor's protocol ID
- 111684
- Status last verified
- Feb 2018
- First submitted
- 25 Jun 2008
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
- ClinicalTrials.gov ID
- NCT00706199
- Acronym / sponsor ID
- 111684
- Conditions
- Cancer
- Keywords
- bone marrow, antigen expression, volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2008
- Primary completion
- 23 Jan 2009 (actual)
- Study completion
- 23 Jan 2009 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Bone marrow aspirationdonors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspirationCollection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes. | Procedure or surgery | Group A |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by GlaxoSmithKline at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of copies of Wilms' Tumor 1 (WT1) antigen expression in bone marrow (time frame: At Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.