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The Organ Transplant Recipient HPV and Skin Cancer Study

NCT05284877 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No intervention

The study is an observational study without intervention.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Merete Haedersdal

    lead OTHER

Principal Investigators

  • Merete Hædersdal, DMSc, MD · Bispebjerg Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2028-03-31
Completion
2043-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284877 on ClinicalTrials.gov