Investigating HPV and skin cancer risks in organ transplant recipients
The Organ Transplant Recipient HPV and Skin Cancer Study
This study is trying to see if organ transplant recipients have a higher risk of HPV infections and skin cancer compared to people with normal immune systems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 3 sites (Copenhagen NV, Capital Region and 2 other locations) |
| Trial ID | NCT05284877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include solid organ transplant recipients aged 18 and older who have been on stable immunosuppressive treatment for at least three months.
Not a fit: Patients with concomitant bone marrow transplantation or those who have undergone a full hysterectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and prevention strategies for HPV-related cancers in organ transplant recipients.
How similar studies have performed: While there is limited knowledge on this specific population, similar studies have indicated the importance of understanding HPV risks in immunocompromised individuals.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen NV, Capital Region and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.