Chromosome AberrationsNCT01884610
Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors
An observational study of Chromosome Aberrations, run by University College, London.
Trial summary
Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chromosome Aberrations
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jun 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Donors of peripheral blood stem cells, who have agreed to participate in the study
Who may be able to join
- Donors of peripheral blood stem cells
Who cannot join
- Relatives suffering from blood cancer
About this study
Official title: Multi Centre Controlled Study on the Impact of Stem Cell Donation Either After Mobilisation With Granulocyte Colony Stimulating Factor or Bone Marrow Harvest on Unrelated Bone Marrow Donors.
Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors.
The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol.
All participants in the Prospective Arm will be asked to donate one 5-10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5-10ml blood sample at least twice - at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5-10ml sample of blood.
Read the detailed description
The aim of this study is to detect any genetic differences between bone marrow and PBSC unrelated donors, post donation and confirm or refute the observations of "long-term genetic or epigenetic effects" published by Nagler et al[Nagler,A. et al. Exp.Haem (2004) 32;122-30]. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust.
There will be two arms:
- Retrospective arm - the peripheral blood of unrelated donors who donated 3 to 5 years previously will be screened. ii) Prospective arm - peripheral blood of unrelated donors will be examined prior to donation and at 120 and 360 day's post-donation. In those found to have aneuploid changes at these time points, there will be additional sampling at 24 and 36 months and if necessary these donors will be followed up.
Each arm of the study will include 50 BM unrelated donors and 50 PBSC unrelated donors giving a total sample population of around 200 unrelated donors. There will be one positive control group of 50 patients with a range of haematological malignancies. The blood samples taken from both BM and PBSC donors prior to donation will act as internal negative controls.
- Conditions
- Chromosome Aberrations
- Medical subject headings
- Chromosome Aberrations
What is being measured
The primary outcome is the main question the study is designed to answer.
Chromosome aberration in peripheral blood lymphocytes
Peripheral blood stem cells donors who have been administered GCSF are monitored for genetic damage. This is performed by screening samples of peripheral blood lymphocytes taken before and after GCSF administration (at day 0, day 90 and day 180) for chromosome aberrations using FISH (fluorescence in situ hybridisation) methodology.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startSep 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosome AberrationsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Bone Marrow Registry, Anthony Nolan Research Institute
- Responsible party
- Sponsor
- Investigators
- Elisabeth P Nacheva, MD PhD FRCPath, Principal investigator, University College London (UCL) Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884610
- Sponsor's protocol ID
- BRD/06/143
- Status last verified
- May 2013
- First submitted
- 18 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Centre Controlled Study on the Impact of Stem Cell Donation Either After Mobilisation With Granulocyte Colony Stimulating Factor or Bone Marrow Harvest on Unrelated Bone Marrow Donors.
- ClinicalTrials.gov ID
- NCT01884610
- Acronym / sponsor ID
- BRD/06/143
- Conditions
- Chromosome Aberrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Bone Marrow Registry, Anthony Nolan Research Institute
- Study start
- Sep 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jun 2013 (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.
Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors.
The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol.
All participants in the Prospective Arm will be asked to donate one 5-10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5-10ml blood sample at least twice - at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5-10ml sample of blood.
Detailed description
The aim of this study is to detect any genetic differences between bone marrow and PBSC unrelated donors, post donation and confirm or refute the observations of "long-term genetic or epigenetic effects" published by Nagler et al[Nagler,A. et al. Exp.Haem (2004) 32;122-30]. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust.
There will be two arms:
- Retrospective arm - the peripheral blood of unrelated donors who donated 3 to 5 years previously will be screened. ii) Prospective arm - peripheral blood of unrelated donors will be examined prior to donation and at 120 and 360 day's post-donation. In those found to have aneuploid changes at these time points, there will be additional sampling at 24 and 36 months and if necessary these donors will be followed up.
Each arm of the study will include 50 BM unrelated donors and 50 PBSC unrelated donors giving a total sample population of around 200 unrelated donors. There will be one positive control group of 50 patients with a range of haematological malignancies. The blood samples taken from both BM and PBSC donors prior to donation will act as internal negative controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Donors of peripheral blood stem cells, who have agreed to participate in the study
Key inclusion criteria (1 listed)
- Donors of peripheral blood stem cells
Key exclusion criteria (1 listed)
- Relatives suffering from blood cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chromosome aberration in peripheral blood lymphocytes
Time frame: 180 days
Peripheral blood stem cells donors who have been administered GCSF are monitored for genetic damage. This is performed by screening samples of peripheral blood lymphocytes taken before and after GCSF administration (at day 0, day 90 and day 180) for chromosome aberrations using FISH (fluorescence in situ hybridisation) methodology.
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 24 Jun 2013.
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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.
Elisabeth P Nacheva, MD PhD FRCPath principal investigator
University College London (UCL) Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Chromosome Aberrations, run by University College, London.
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 1 inclusion and 1 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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Chromosome aberration in peripheral blood lymphocytes (time frame: 180 days). 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 24 Jun 2013.