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.
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 with concomitant bone marrow transplantation
Full hysterectomy
Able patients aged ≥18 years
No known immunosuppressive therapy or -condition
OTRs attending regular skin cancer screening at the Departments of Dermatology at Bispebjerg Hospital (BBH), Gentofte University Hospital (GEH) and Zealand University Hospital Roskilde (ZUH) are eligible for inclusion in the cohort. Approximately 850 OTR patients are currently attending dermatologic screening at BBH, 400 at GEH, and 450 at ZUH. A total of 900 OTRs (300 men and 600 women) will be included. Patient inclusion will be distributed between the three dermatologic departments. An immunocompetent control group of women (n=600) will be recruited from the outpatient clinic at the Departments of Dermatology BBH, GEH and ZUH. Controls will be matched with female OTRs according to age (categories 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, ≥70 years).
Cohort
Prospective
No intervention
Other interventionThe study is an observational study without intervention.
Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.
Number of women with cervical HPV infection measured by PCR test.
Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
Number of women with oral HPV infection measured by PCR test.
Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs.
Lifestyle factors determined by questionnaire. Clinical factors from medical records. Number of women with cervical HPV infection measured by PCR test.
Correlations between lifestyle factors, clinical factors and occurrence of oral HPV infection in female OTRs.
Lifestyle factors determined by questionnaire. Clinical factors from medical records. Number of women with oral HPV infection measured by PCR test.
Difference in prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared to immunocompetent controls.
Number of women with HPV-related dysplasia and HPV-related cancer from registries using registry linkage.
Click on the lead sponsor to view all of their trials.
Merete Haedersdal
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Danish Cancer Society
Collaborator
Zealand University Hospital
Collaborator
Vejle Hospital
Collaborator
Herlev and Gentofte Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
