Clinical trial · Observational
The Organ Transplant Recipient HPV and Skin Cancer Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HPV Infection | — | UNRESOLVED | — |
| HPV-Related Malignancy | Human Papillomavirus-Related Malignant Neoplasm | ALIAS | 0.90 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Dysplasia | — | UNRESOLVED | — |
| Solid Organ Transplant Recipient | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Male organ transplant recipients
- description
- 300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)
- interventionNames
- Other: No intervention
- label
- Female organ transplant recipients
- description
- 600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)
- interventionNames
- Other: No intervention
- label
- Female immunocompetent controls
- description
- 600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments
- interventionNames
- Other: No intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available