This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.
Eligibility
Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
* Patients who received allogeneic HSCT between January 2018 and June 2020;
* Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Exclusion Criteria:
* Letermovir use at any time
Primary outcome measure(s)
Summary of demographic and baseline characteristics — at baseline (day of transplant) Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT — at baseline (day of transplant) Proportion of patients CMV R+ at transplantation. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
CMV serostatus — at baseline (day of transplant) R+/D-, R+/D+ and R-/D+ combination frequencies. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Donor type — at baseline (day of transplant) Allogeneic HSCT characteristics
Stem cell source — at baseline (day of transplant) Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Conditioning intensity — at baseline (day of transplant) Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Underlying condition — at baseline (day of transplant) Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Usage of immunosuppression — at baseline (day of transplant) Allogeneic Hematopoietic Stem Cells Transplantation characteristics
Current standard of care in CMV management in terms of PET approach — during the first-year post-transplant It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of GCV prophylaxis — during the first-year post-transplant It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of ACV prophylaxis — during the first-year post-transplant It will be described quantitatively by tabulating frequencies and percentages.
Current standard of care in CMV management in terms of other — during the first-year post-transplant It will be described quantitatively by tabulating frequencies and percentages.
Trial sites (5)
Facility
City
Region
Status
IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
Genova
Italy
Recruiting
Ospedale San Gerardo, Clinica Pediatrica
Monza
Italy
Recruiting
Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
Padova
Italy
Not Yet Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
Roma
Italy
Recruiting
Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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