Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors

This study has been completed.
Sponsor:
Collaborators:
British Bone Marrow Registry
Anthony Nolan Research Institute
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01884610
First received: June 18, 2013
Last updated: June 19, 2013
Last verified: May 2013
  Purpose

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.


Condition
Chromosome Aberrations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Chromosome aberration in peripheral blood lymphocytes [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples With DNA

Fixed ( methanol/acetic acid ) chromosome preparations solution and genomic DNA.


Enrollment: 50
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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:

i) 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Donors of peripheral blood stem cells, who have agreed to participate in the study

Criteria

Inclusion Criteria:

Donors of peripheral blood stem cells

Exclusion Criteria:

Relatives suffering from blood cancer

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884610

Sponsors and Collaborators
University College, London
British Bone Marrow Registry
Anthony Nolan Research Institute
Investigators
Principal Investigator: Elisabeth P Nacheva, MD PhD FRCPath University College London (UCL) Cancer Institute
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01884610     History of Changes
Other Study ID Numbers: BRD/06/143
Study First Received: June 18, 2013
Last Updated: June 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chromosome Aberrations
Chromosome Disorders
Pathologic Processes
Congenital Abnormalities
Genetic Diseases, Inborn
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014