Investigating HPV and skin cancer risks in organ transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the long-term effects of immunosuppression on skin and mucosal health in solid organ transplant recipients (OTRs). It will compare the prevalence and incidence of cervical and oral HPV infections, as well as skin dysplasia and cancer, between OTRs and immunocompetent controls. The study will involve a cohort of 1,500 participants, including 600 female OTRs, 300 male OTRs, and 600 female controls, who will undergo various assessments including questionnaires, dermatologic evaluations, and HPV testing. The findings will enhance understanding of the risks associated with immunosuppressive therapy in OTRs.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Dermatology, Bispebjerg Hospital
  Copenhagen NV, Capital Region, Denmark Recruiting
• Department of Dermatology and Allergy, Herlev og Gentofte Hospital
  Hellerup, Capital Region, Denmark Recruiting
• Department of Dermatology, Zealand University Hospital
  Roskilde, Region Sjælland, Denmark Recruiting

Study contacts

• Principal investigator: Merete Hædersdal, DMSc, MD — Bispebjerg Hospital
• Study coordinator: Lene Rask
• Email: lene.rask.01@regionh.dk
• Phone: +45 23359940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.