HHV8NCT05081141
HHV8 and Solid Organ Transplantation
An observational study of HHV8 and HHV8 Infection, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HHV8, HHV8 Infection, HHV8-Related Malignant Neoplasm
- What is being tested?
- Diagnostic test for HHV8 exposure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will include all the donors being used for transplantation purposes at our centre and the respective recipients.
Who may be able to join
- all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation
- All patients listed for solid organ transplantation (lung, liver and kidney)
Who cannot join
- None
- SOT CANDIDATES RECIPIENTS:
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
Valeria Rossetti, MD, 00393395605478, valeria.rossetti@policlinico.mi.it
Letizia Corinna Morlacchi, MD, 00393338158766, letizia.morlacchi@policlinico.mi.it
About this study
Official title: Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients
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.
Read the detailed description
Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8.
As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed.
AFTER SOLID ORGAN TRANSPLANTATION
- Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant.
- In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation).
- With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).
- Conditions
- HHV8, HHV8 Infection, HHV8-Related Malignant Neoplasm, Kaposi Sarcoma, Lung Transplant; Complications, Liver Transplant; Complications
- Being tested
- Diagnostic test for HHV8 exposure
- Keywords
- HHV8, Solid organ transplant, Lung transplant, Liver transplant, Kidney transplant, Kaposi Sarcoma, Castleman Disease
- Medical subject headings
- Sarcoma, Kaposi, Castleman Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test for HHV8 exposureDiagnostic test
Venipuncture for blood sampling
| Study group | Role | What they receive |
|---|---|---|
| SOT Donors | Solid organ transplantation donors Receives: Diagnostic Test: Diagnostic test for HHV8 exposure | |
| LuTx candidates and recipients | Lung transplant candidates and recipients Receives: Diagnostic Test: Diagnostic test for HHV8 exposure | |
| LTx candidates and recipients | Liver transplant candidates and recipients Receives: Diagnostic Test: Diagnostic test for HHV8 exposure | |
| KTx candidates and recipients | Kidney transplant candidates and recipients Receives: Diagnostic Test: Diagnostic test for HHV8 exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HHV8 seropositivity among SOT donors and recipients
Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients
Measured: 2021-2024
Incidence of HHV8 mismatch between SOT donors and recipients
Incidence of HHV8 mismatch between solid organ transplantations donors and recipients
Measured: 2021-2024
Secondary outcomes (1)
Incidence of HHV8 related disease after solid organ transplantation
Incidence of HHV8 related disease after solid organ transplantation
Measured: 2021-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HHV8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081141
- Sponsor's protocol ID
- S_OTTO
- Status last verified
- May 2024
- First submitted
- 4 Oct 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26658701Chiereghin 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.
PubMed 28333859Pietrosi 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.
PubMed 21966899Riva 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.
PubMed 22968461Tzannou 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.
PubMed 28783452
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients
- ClinicalTrials.gov ID
- NCT05081141
- Acronym / sponsor ID
- S_OTTO
- Conditions
- HHV8, HHV8 Infection, HHV8-Related Malignant Neoplasm, Kaposi Sarcoma, Lung Transplant; Complications, Liver Transplant; Complications
- Keywords
- HHV8, Solid organ transplant, Lung transplant, Liver transplant, Kidney transplant, Kaposi Sarcoma, Castleman Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8.
As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed.
AFTER SOLID ORGAN TRANSPLANTATION
- Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant.
- In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation).
- With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOT Donors | – | Diagnostic Test: Diagnostic test for HHV8 exposureSolid organ transplantation donors |
| LuTx candidates and recipients | – | Diagnostic Test: Diagnostic test for HHV8 exposureLung transplant candidates and recipients |
| LTx candidates and recipients | – | Diagnostic Test: Diagnostic test for HHV8 exposureLiver transplant candidates and recipients |
| KTx candidates and recipients | – | Diagnostic Test: Diagnostic test for HHV8 exposureKidney transplant candidates and recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will include all the donors being used for transplantation purposes at our centre and the respective recipients.
Key inclusion criteria (2 listed)
- all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation
- All patients listed for solid organ transplantation (lung, liver and kidney)
Key exclusion criteria (3 listed)
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test for HHV8 exposureVenipuncture for blood sampling | Diagnostic test | KTx candidates and recipients, LTx candidates and recipients, LuTx candidates and recipients, SOT Donors |
Primary outcome
Incidence of HHV8 seropositivity among SOT donors and recipients
Time frame: 2021-2024
Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients
Incidence of HHV8 mismatch between SOT donors and recipients
Time frame: 2021-2024
Incidence of HHV8 mismatch between solid organ transplantations donors and recipients
1 secondary outcome
Incidence of HHV8 related disease after solid organ transplantation
Time frame: 2021-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 26658701Polizzotto 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.
- Background: PubMed 28333859Chiereghin 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.
- Background: PubMed 21966899Pietrosi 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.
- Background: PubMed 22968461Riva 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.
- Background: PubMed 28783452Tzannou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HHV8 and HHV8 Infection, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Rossetti, MD (0039 2 55033782, valeria.rossetti@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HHV8 seropositivity among SOT donors and recipients (time frame: 2021-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081141, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.