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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.

Timeframe: Evaluated at baseline and month 12

Trial details

NCT IDNCT05284877

SponsorMerete Haedersdal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-03

Contact for this trial

Lene Rask

+45 23359940 lene.rask.01@regionh.dk

View on ClinicalTrials.gov More Solid Organ Transplant Recipient trials