HHV8 and Solid Organ Transplantation
Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients
1 other identifier
observational
250
1 country
1
Brief Summary
Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2021
CompletedFirst Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 7, 2024
May 1, 2024
3.3 years
October 4, 2021
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of HHV8 seropositivity among SOT donors and recipients
Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients
2021-2024
Incidence of HHV8 mismatch between SOT donors and recipients
Incidence of HHV8 mismatch between solid organ transplantations donors and recipients
2021-2024
Secondary Outcomes (1)
Incidence of HHV8 related disease after solid organ transplantation
2021-2025
Study Arms (4)
SOT Donors
Solid organ transplantation donors
LuTx candidates and recipients
Lung transplant candidates and recipients
LTx candidates and recipients
Liver transplant candidates and recipients
KTx candidates and recipients
Kidney transplant candidates and recipients
Interventions
Venipuncture for blood sampling
Eligibility Criteria
We will include all the donors being used for transplantation purposes at our centre and the respective recipients.
You may qualify if:
- all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation
You may not qualify if:
- None
- SOT CANDIDATES RECIPIENTS:
- All patients listed for solid organ transplantation (lung, liver and kidney)
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122, Italy
Related Publications (5)
Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Marshall V, Wang V, Whitby D, Pittaluga S, Jaffe ES, Millo C, Tosato G, Little RF, Steinberg SM, Sereti I, Yarchoan R. Clinical Features and Outcomes of Patients With Symptomatic Kaposi Sarcoma Herpesvirus (KSHV)-associated Inflammation: Prospective Characterization of KSHV Inflammatory Cytokine Syndrome (KICS). Clin Infect Dis. 2016 Mar 15;62(6):730-738. doi: 10.1093/cid/civ996. Epub 2015 Dec 12.
PMID: 26658701BACKGROUNDChiereghin A, Barozzi P, Petrisli E, Piccirilli G, Gabrielli L, Riva G, Potenza L, Cappelli G, De Ruvo N, Libri I, Maggiore U, Morelli MC, Potena L, Todeschini P, Gibertoni D, Labanti M, Sangiorgi G, La Manna G, Pinna AD, Luppi M, Lazzarotto T. Multicenter Prospective Study for Laboratory Diagnosis of HHV8 Infection in Solid Organ Donors and Transplant Recipients and Evaluation of the Clinical Impact After Transplantation. Transplantation. 2017 Aug;101(8):1935-1944. doi: 10.1097/TP.0000000000001740.
PMID: 28333859BACKGROUNDPietrosi G, Vizzini G, Pipitone L, Di Martino G, Minervini MI, Lo Iacono G, Conaldi PG, Grossi P, Lamonaca V, Galatioto L, Gruttadauria S, Gridelli B. Primary and reactivated HHV8 infection and disease after liver transplantation: a prospective study. Am J Transplant. 2011 Dec;11(12):2715-23. doi: 10.1111/j.1600-6143.2011.03769.x. Epub 2011 Oct 3.
PMID: 21966899BACKGROUNDRiva G, Luppi M, Barozzi P, Forghieri F, Potenza L. How I treat HHV8/KSHV-related diseases in posttransplant patients. Blood. 2012 Nov 15;120(20):4150-9. doi: 10.1182/blood-2012-04-421412. Epub 2012 Sep 11.
PMID: 22968461BACKGROUNDTzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
PMID: 28783452BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2021
First Posted
October 18, 2021
Study Start
September 15, 2021
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
May 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share