The Organ Transplant Recipient HPV and Skin Cancer Study (NCT05284877) | Clinical Trial Compass
RecruitingNot Applicable
The Organ Transplant Recipient HPV and Skin Cancer Study
Denmark1,500 participantsStarted 2022-03-10
Plain-language summary
Solid organ transplant recipients (OTRs) receive lifelong immunosuppressive therapy, which puts them at increased risk of cutaneous and mucosal cancers. In particular, OTRs have increased risk of skin cancer and cancers caused by human papillomavirus (HPV), including cervical cancer and oropharyngeal cancer. There is currently limited knowledge on risk factors for HPV infection and skin cancer in OTRs, and limited knowledge on the natural history of HPV infection and cervical neoplasia in OTRs compared with immunocompetent controls. With a continuously increasing number of OTRs, there is a growing need to improve our understanding of the long-term reactions to immunosuppression.
The overall aim of this study is to investigate long term effects of immunosuppression on cutaneous and mucosal epithelium in Danish OTRs, including the risk of skin dysplasia and skin cancer, cervical and oral HPV infection and HPV-related dysplasia and cancer in OTRs.
This study will be designed as a prospective observational cohort study based on clinical data and data from nationwide Danish registries. A total of 600 female OTRs, 300 male OTRs and 600 female controls will be included from Danish dermatology departments.
The study aims to provide knowledge relevant for improving prevention of skin- and HPV-related cancers in OTRs, including personalized screening recommendations according to individual patient risk.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for OTRs:
* Patients aged ≥18 years
* Solid organ transplantation recipients, i.e. kidney-, liver-, lung-, and heart transplant recipients
* Stable immunosuppressive treatment for ≥3 months
* No signs of acute graft rejection
* Patients who reside in Denmark
* Informed written consent obtained
Exclusion Criteria for OTRs:
* Patients with concomitant bone marrow transplantation
* Full hysterectomy
Inclusion Criteria for Control group:
* Able patients aged ≥18 years
* No known immunosuppressive therapy or -condition
* Patients who reside in Denmark
* Informed written consent obtained
Exclusion Criteria for Control group:
\- Full hysterectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is comparing HPV infection rates in organ transplant recipients like me to people with normal immune systems, can you help me understand whether my immunosuppression medications are already known to put me at higher risk for HPV-related cervical problems, and what that means for my current care?
2This trial is observational — meaning it seems to be tracking and measuring HPV infection over time rather than testing a new treatment — so what would actually be done to me if I participated, and would it change anything about how my cervical health is monitored right now?
3The study is looking at cervical HPV infection specifically in female organ transplant recipients, so would joining this trial give me access to more frequent cervical screenings or HPV testing than I'd normally receive as part of my transplant follow-up?
4Given that this trial is still recruiting and the results aren't in yet, are there already existing clinical guidelines for managing HPV and cervical cancer risk in transplant recipients that my care team is following, and would this study add anything beyond what those guidelines already recommend?
5If I choose not to participate in this study, is there anything about my skin cancer or HPV screening routine that my transplant team would do differently, or would my monitoring stay the same either way?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.