NCT05284877 The Organ Transplant Recipient HPV and Skin Cancer Study
| NCT ID | NCT05284877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Merete Haedersdal |
| Condition | Solid Organ Transplant Recipient |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2022-03-10 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2022-03-10 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria for OTRs: * 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 Exclusion Criteria for OTRs: * Patients with concomitant bone marrow transplantation * Full hysterectomy Inclusion Criteria for Control group: * Able patients aged ≥18 years * No known immunosuppressive therapy or -condition * Patients who reside in Denmark * Informed written consent obtained Exclusion Criteria for Control group: \- Full hysterectomy
Contact & Investigator
Merete Hædersdal, DMSc, MD
PRINCIPAL INVESTIGATOR
Bispebjerg Hospital
Frequently Asked Questions
Who can join the NCT05284877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Organ Transplant Recipient. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05284877 currently recruiting?
Yes, NCT05284877 is actively recruiting participants. Contact the research team at lene.rask.01@regionh.dk for enrollment information.
Where is the NCT05284877 trial being conducted?
This trial is being conducted at Copenhagen NV, Denmark, Hellerup, Denmark, Roskilde, Denmark.
Who is sponsoring the NCT05284877 clinical trial?
NCT05284877 is sponsored by Merete Haedersdal. The principal investigator is Merete Hædersdal, DMSc, MD at Bispebjerg Hospital. The trial plans to enroll 1,500 participants.