Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-06-06
2028-08-31
Brief Summary
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Detailed Description
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Patients will be recruited and consented prior to admission for HSCT. Enrolled patients will undergo sequential blood collection beginning prior to conditioning, then on the day of transplant (day 0), followed by days 7, 14, 21, 28, 56 (2 months) and 90 (3 months) post-transplant. Samples will be collected, processed, and stored by the MCRC Biobank. The period of observation for each patient is 6-months. Clinical data will be collected prospectively: 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, these are typically performed around day 100 and whenever there is suspicion of disease recurrence. The study aims to identify all patients who develop aGvHD, collecting an additional blood sample at the onset of treatment for those who receive systemic corticosteroids (PO or IV steroid equivalent to ≥0.5mg/kg prednisolone). Additional clinical data will be collected at treatment onset and 7, 14, 21 and 28 days after starting systemic corticosteroids. These assessments will provide the clinical data necessary to establish diagnostic confidence, severity at onset/peak, response to treatment and outcome.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood sample collection
Enrolled patients will undergo sequential blood collection beginning prior to conditioning, then on the day of transplant (day 0), followed by days 7, 14, 21, 28, 56 (2 months) and 90 (3 months) post-transplant.
Bone marrow aspirates taken within this period as part of routine care will also be collected, these are typically performed around day 100 and whenever there is suspicion of disease recurrence.
The study will also collect an additional blood sample at the onset of treatment for aGvHD for those who receive systemic corticosteroids (PO or IV steroid equivalent to ≥0.5mg/kg prednisolone).
Bone marrow aspirate
Bone marrow aspirates taken within this period as part of routine care will also be collected, these are typically performed around day 100 and whenever there is suspicion of disease recurrence.
Eligibility Criteria
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Inclusion Criteria
* Children/infants may participate, there is no age restriction
* Patients participating in other clinical trials remain eligible
Exclusion Criteria
* Recipients of autologous stem cell transplants
ALL
No
Sponsors
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The Christie NHS Foundation Trust
OTHER
University of Manchester
OTHER
Responsible Party
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Mark Williams
Principal Investigator
Principal Investigators
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Mark Williams
Role: PRINCIPAL_INVESTIGATOR
CRUK Manchester Institute
Locations
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Manchester Royal Infirmary
Manchester, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS ID: 262284
Identifier Type: -
Identifier Source: org_study_id
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