NCT05284877Recruiting
The Organ Transplant Recipient HPV and Skin Cancer Study
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- 10 Mar 2022
- Primary completion date
- Mar 2028
- Lead sponsor
- Merete Haedersdal
- Diseases
- Cervical cancer
- NCT number
- NCT05284877
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 10 Mar 2022 to the primary completion date, Mar 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant bone marrow transplantation
Other
- Full hysterectomy
- \- Full hysterectomy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Dermatology, Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen NV | Denmark | Recruiting |
| Department of Dermatology and Allergy, Herlev og Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Recruiting |
| Department of Dermatology, Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.