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

NCT01884610 | Completed DMC

• 1 other identifier: BRD/06/143
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chromosome Aberrations

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Donors of peripheral blood stem cells

You may not qualify if:

• Relatives suffering from blood cancer

Sponsors & Collaborators

• University College, London: lead
• British Bone Marrow Registry: collaborator
• Anthony Nolan Research Institute: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Chromosome Aberrations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth P Nacheva, MD PhD FRCPath

  University College London (UCL) Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 24, 2013
• Study Start: September 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 24, 2013

Record last verified: 2013-05