PM-SCT
Research type
Research Study
Full title
Precision Medicine for Stem Cell Transplantation
IRAS ID
262284
Contact name
Mark Williams
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, NCT05567289
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
This study concerns patients undergoing haematopoietic stem cell transplantation, a procedure in which patients are infused with stem cells from a donor, resulting in a new immune system that eliminates cancer or replaces diseased bone marrow. This study aims to develop new blood tests that predict the onset of acute graft-versus-host disease (aGvHD) and leukaemia relapse, two life-threatening complications that frequently limit the success of treatment. Predictive tests would allow doctors to individualise prophylaxis and intervene early to abort complications before they develop. The study will also create a large collection of clinically annotated blood samples from 300 transplant recipients to support future research and provide a resource to the transplant research community.
Patients will be recruited from participating NHS transplant centres and consented prior to admission for transplant. Participants will undergo blood collection at 8 time points, their treatment will not be affected in any way. Samples will be collected, processed, and stored by the Manchester Cancer Research Centre Biobank. The period of observation for each patient is 6-months. Clinical data will be collected on admission, with each blood sample, and at 6-months post-transplant. Bone marrow aspirates taken within this period as part of routine care will also be collected. The study aims to identify all patients who develop aGvHD, collecting an additional blood sample at the onset of treatment and additional clinical data at treatment onset and 7, 14, 21 and 28 days afterwards. These assessments will provide the clinical data necessary to establish diagnostic confidence, severity at onset/peak, response to treatment and outcome.
Funding for this study has been provided by The Christie Charity. Funding for the subsequent biomarker development has been provided by the Manchester Cancer Research Centre (predictive aGvHD biomarkers) and the Medical Research Council (biomarkers of leukaemia relapse).
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0008
Date of REC Opinion
16 Jan 2023
REC opinion
Favourable Opinion