ST2 and REG3 alpha as acute GVHD biomarkers in paediatric patients
Research type
Research Study
Full title
A prospective non interventional study to validate the role of ST2 and REG3 alpha as biomarkers of Acute graft versus host (GVHD) in a paediatric population of patients (STREGA)
IRAS ID
281701
Contact name
Juliana Silva
Contact email
Sponsor organisation
Great Ormond Street Hospital
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Allogeneic stem cell transplantation is a standard of care life saving procedure for many children affected by cancer or by congenital disorders. The procedure involves substituting the malfunctional bone marrow of the patient with a healthy bone marrow from a donor. Transplant is quite complex and among the significant risks that it carries there is that of a severe reaction between the infused cells of the donor and the organs of the recipient. This reaction goes under the name of graft versus host disease (GVHD) and can be as severe as to become life-threatening. At the moment there are known risk factors for GVHD but there is no real possibility of understanding in advance whether a patient will develop a mild or a severe form of GVHD. This is quite crucial as having such an idea would allow to tailor pharmacological treatment that the patient requires to prevent or treat GVHD, avoiding unnecessary toxicities. A group of American and European scientists have identified some potential substances that are shed very early after transplantation in the blood of the patient and that could potentially predict the risk for GVHD and its severity early after transplant. Those substances are called biomarkers, in details they are REG3alfa and ST2. The available data so far are mostly related to adult patients, and given stem cell transplant in adults is performed in a different way than in children we cannot be sure those biomarkers will be as useful in children as they are for adults. With the present study we aim to test those substances in the blood of our transplanted pediatric patients early post stem cell transplantation to understand if they are reliable predictors of severe GVHD and GVHD related early mortality.
REC name
West of Scotland REC 3
REC reference
22/WS/0092
Date of REC Opinion
30 Jun 2022
REC opinion
Favourable Opinion