Status:
ACTIVE_NOT_RECRUITING
Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Graft-versus-host Disease
Eligibility:
All Genders
1-100 years
Brief Summary
Recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-SCT) recipients might influence incidence and severity of acute g...
Eligibility Criteria
Inclusion
- Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.
- Patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis.
- Agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable).
- Exclusion Criteria
- \- Allotransplant recipients in stages after the initial pre-conditioning.
- Donors
- Family donors from patients included in the study:
- Inclusion criteria:
- Agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable).
- Donor relatives with any degree of identity in the Human Leukocyte Antigens (HLA).
Exclusion
- Unrelated donors
- Transplants from umbilical cord blood source.
Key Trial Info
Start Date :
January 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05186857
Start Date
January 23 2023
End Date
December 1 2025
Last Update
March 18 2024
Active Locations (9)
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1
Hospital Universitario Virgen del Rocío, Sevilla
Seville, Seville, Spain
2
Hospital Universitario Reina Sofía
Córdoba, Spain
3
Hospital Virgen de las Nieves de Granada
Granada, Spain
4
Hospital del Niño Jesús, Madrid
Madrid, Spain