Prospective Survey of CMV, Herpesviruses Infections and Diseases in Allo-HSCT
CYTOALLOSURVEY
A Prospective, Multicenter Survey of Cytomegalovirus (CMV) and Other Herpesviruses Infections and Diseases in Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Recipients.
1 other identifier
observational
1,310
1 country
50
Brief Summary
Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment) from GITMO investigational centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJanuary 6, 2025
January 1, 2025
1.6 years
May 29, 2020
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Cytomegalovirus infection
incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Cytomegalovirus disease
incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Herpesvirus human 6 infection
incidence of human 6 infection after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Herpesvirus human 6 disease
incidence of human 6 disease after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Virus Epstein-Barr infection
incidence of Virus Epstein-Barr infections after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Virus Epstein-Barr disease
incidence of Virus Epstein-Barr disease after allogeneic haematopoietic stem cell transplantation
6 months from transplant
Secondary Outcomes (6)
Overall Survival (OS)
These outcome measures will be assessed at 1 year from transplant
Disease Free Survival (DFS)
These outcome measures will be assessed at 1 year from transplant
Transplant Related Mortality (TRM)
These outcome measures will be assessed at 1 year from transplant
Relapse risk (RR)
These outcome measures will be assessed at 1 year from transplant
Acute Graft-versus-Host Disease
These outcome measures will be assessed at 100 days from transplant
- +1 more secondary outcomes
Study Arms (1)
Patients with hematological disease
Adult and children allogenic Hematopoietic stem cell transplantation recipients
Eligibility Criteria
Adult and children allogenic Hematopoietic stem cell transplantation recipients
You may qualify if:
- Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects, with competitive enrolment from GITMO investigational centers.
You may not qualify if:
- Absence of consent Written information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Ospedale San Carlo
Potenza, Italy, Italy
Policlinico GB Rossi
Verona, Italy, Italy
UO Ematologia e TMO - Ospedale C. Panico
Tricase, Lecce, Italy
A.O.U. Policlinico Federico II
Napoli, Napoli, Italy
Fondazione IRCCS San Matteo
Pavia, Pavia, 27100, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, Italy
Ospedale Mazzoni
Ascoli Piceno, Italy
A.O.S. G. Moscati
Avellino, Italy
Policlinico di Bari-Ematologia con trapianti
Bari, Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
A.O.U. Policlinico S.Orsola-Malpighi
Bologna, Italy
Ospedale San Orsola
Bologna, Italy
Ospedale Regionale Generale- Divisione Ematologia
Bolzano, Italy
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, Italy
Azienda Sanitaria Locale Br1 Ospedale "A. Perrino
Brindisi, Italy
CTMO PO "Businco" A.O. "G. Brotzu"
Cagliari, Italy
Ospedale Ferrarotto
Catania, Italy
Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy
Azienda Ospedaliera di Careggi
Florence, Italy
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
Foggia, Italy
AOU-IRCCS San Martino-IST
Genova, Italy
Ospedale Gaslini
Genova, Italy
Policlinico VIto Fazzi
Lecce, Italy
AOU Integrata
Mestre, Italy
Divisione di Ematologia - Istituto Nazionale dei Tumori
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
Modena, Italy
Ospedale San Gerardo
Monza, Italy
AOU S. Giovanni di Dio e Ruggi D'Aragona
Napoli, Italy
Uoc Sit Tmo
Napoli, Italy
UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli
Napoli, Italy
Azienda Ospedaliera di Padova
Padua, Italy
CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Azienda ospedaliera Universitaria di Parma
Parma, Italy
Policlinico San Matteo
Pavia, Italy
Ospedale S. Maria della Misericordia
Perugia, Italy
Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
Pescara, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria, Italy
Arciospedale S. M. Novella
Reggio Emilia, Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
Roma, Italy
Ospedale Bambin Gesù
Roma, Italy
Policlinico Tor Vergata
Roma, Italy
Policlinico Umberto I
Roma, Italy
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
Rozzano (MI), Italy
Ospedale Moscati
Taranto, Italy
AOU CIttà della Salute e della Scienza
Torino, Italy
Ospedale Regina Margherita
Torino, Italy
A.O. Santa Maria della Misericordia
Udine, Italy
Related Publications (1)
Girmenia C, Chiusolo P, Marsili G, Piciocchi A, Mico MC, Greco R, Porto G, Galaverna F, Bonifazi F, Cutini I, Malagola M, Bramanti S, Busca A, Carella AM, Carotti A, Iori AP, Onida F, Bono R, Terruzzi E, Vacca A, Rinaldi A, Cavattoni IM, Picardi A, Faraci M, Lazzarotto T, Baldanti F, Clerici P, Castagna L, Martino M, Ciceri F. The Changing Impact of Human Cytomegalovirus Serology and Infection on Patient Outcome After Allogeneic Hematopoietic Stem Cell Transplantation: An Italian Prospective Multicenter Survey in the Era of Letermovir Prophylaxis. Open Forum Infect Dis. 2025 Apr 18;12(5):ofaf233. doi: 10.1093/ofid/ofaf233. eCollection 2025 May.
PMID: 40322267DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corrado Girmenia
Azienda Policlinico Umberto I
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 2, 2020
Study Start
January 1, 2021
Primary Completion
July 31, 2022
Study Completion
March 31, 2023
Last Updated
January 6, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share