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RECRUITING
NCT05284877

The Organ Transplant Recipient HPV and Skin Cancer Study

Sponsor: Merete Haedersdal

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2022-03-10

Completion Date

2043-03

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

OTHER

No intervention

The study is an observational study without intervention.

Locations (3)

Department of Dermatology, Bispebjerg Hospital

Copenhagen NV, Capital Region, Denmark

Department of Dermatology and Allergy, Herlev og Gentofte Hospital

Hellerup, Capital Region, Denmark

Department of Dermatology, Zealand University Hospital

Roskilde, Region Sjælland, Denmark