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The Organ Transplant Recipient HPV and Skin Cancer Study

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date: Apr 2027 to Mar 2028v5 Show 4 more changesShow less
    • Enrollment target: 1800 to 1500
    • Study completion date: Apr 2027 to Mar 2043
    • Study description revised
    • Site contacts updated at 1 of 3 sites
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Site details revised at 2 of 3 sitesv3
  4. Minor Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 10 entries
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05284877
Lead Sponsor Merete Haedersdal
Collaborators: Danish Cancer Society, Zealand University Hospital, Vejle Hospital, Herlev and Gentofte Hospital, Rigshospitalet, Denmark
Conditions
(from sponsor)
Solid Organ Transplant Recipient, Skin Cancer, Skin Dysplasia, HPV Infection, Cervical Intraepithelial Neoplasia, Cervical Cancer, HPV-Related Malignancy
Related terms Papillomavirus Infections, Skin Neoplasms, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov