RecruitingNCT05284877

The Organ Transplant Recipient HPV and Skin Cancer Study


Sponsor

Merete Haedersdal

Enrollment

1,500 participants

Start Date

Mar 10, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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
  • Able patients aged ≥18 years
  • No known immunosuppressive therapy or -condition
  • Patients who reside in Denmark
  • Informed written consent obtained

Exclusion Criteria3

  • Patients with concomitant bone marrow transplantation
  • Full hysterectomy
  • \- Full hysterectomy

Interventions

OTHERNo 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

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NCT05284877


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