An observational study in Solid Organ Transplant Recipient, Skin Cancer and Skin Dysplasia, sponsored by Merete Haedersdal. Recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Merete Haedersdal · Observational
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.
AIMS
The specific research objectives of this study are:
METHODS
The study will be designed as a clinical prospective cohort study. A total of 600 female OTRs, 300 male OTRs and 600 female immunocompetent controls will be included from the Departments of Dermatology at Bispebjerg, Gentofte and Roskilde Hospitals, Denmark.
The following data will be collected from OTRs:
The following data will be collected from female immunocompetent controls:
A REDCap database will be established for study data. The RedCap database is encrypted and accessed electronically with personal user-ID and password.
The study population will be linked with nationwide Danish registries and clinical databases. From these registers information on cases of precancerous lesions and cancer; other HPV-related conditions; participation in HPV vaccination and cervical cancer screening; co-morbidities, pregnancies, births and medicine use; socio-demographic characteristics; and emigration and death of women in the study population will be obtained. Registry linkage will be performed for up to 15 years after end of study.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 400 across 147 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Merete Haedersdal is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
OTRs attending regular skin cancer screening at the Departments of Dermatology at Bispebjerg Hospital (BBH), Gentofte University Hospital (GEH) and Zealand University Hospital Roskilde (ZUH) are eligible for inclusion in the cohort. Approximately 850 OTR patients are currently attending dermatologic screening at BBH, 400 at GEH, and 450 at ZUH.
A total of 900 OTRs (300 men and 600 women) will be included. Patient inclusion will be distributed between the three dermatologic departments.
An immunocompetent control group of women (n=600) will be recruited from the outpatient clinic at the Departments of Dermatology BBH, GEH and ZUH. Controls will be matched with female OTRs according to age (categories 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, ≥70 years).
Inclusion Criteria for OTRs:
Exclusion Criteria for OTRs:
Inclusion Criteria for Control group:
Exclusion Criteria for Control group:
300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Other: No intervention
600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Other: No intervention
600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments
Other: No intervention
The study is an observational study without intervention.
Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.
Number of women with cervical HPV infection measured by PCR test.
Time frame: Evaluated at baseline and month 12
Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
Number of women with oral HPV infection measured by PCR test.
Time frame: Evaluated at baseline
Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs.
Lifestyle factors determined by questionnaire. Clinical factors from medical records. Number of women with cervical HPV infection measured by PCR test.
Time frame: Evaluated at baseline
Correlations between lifestyle factors, clinical factors and occurrence of oral HPV infection in female OTRs.
Lifestyle factors determined by questionnaire. Clinical factors from medical records. Number of women with oral HPV infection measured by PCR test.
Time frame: Evaluated at baseline
Difference in prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared to immunocompetent controls.
Number of women with HPV-related dysplasia and HPV-related cancer from registries using registry linkage.
Time frame: Evaluated at baseline and during up to 15 years after baseline.
Correlations between lifestyle factors, clinical factors and prevalence of skin dysplasia and cancer in OTRs.
Lifestyle factors determined by a questionnaire. Clinical factors from medical records. Skin dysplasia and skin cancer assessed by clinical evaluation and by non-invasive imaging.
Time frame: Evaluated at baseline
Correlation between Vitamin D and prevalence of skin dysplasia and cancer in OTRs.
Vitamin D from blood sample analysis. Skin dysplasia and skin cancer assessed by clinical evaluation and non-invasive imaging.
Time frame: Evaluated at baseline
Correlations between skin pigmentation, facial solar lentigines and prevalence of skin dysplasia and cancer in OTRs.
Skin pigmentation measured with skin reflectance. Facial solar lentigines measured by photographs. Skin dysplasia and skin cancer assessed by clinical evaluation and non-invasive imaging.
Time frame: Evaluated at baseline
Correlation between prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs.
Number of women with cervical HPV infection measured by PCR test. Skin dysplasia and skin cancer assessed by clinical evaluation and non-invasive imaging.
Time frame: Evaluated at baseline
Correlations between history of herpes zoster, prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs.
Number of women with history of herpes zoster determined by questionnaire. Number of women with cervical HPV infection measured by PCR test. Skin dysplasia and skin cancer assessed by clinical evaluation and non-invasive imaging.
Time frame: Evaluated at baseline
Difference in prevalence and incidence of skin cancer in female OTRs compared to immunocompetent controls.
Number of women with skin cancer from registries using registry linkage
Time frame: Evaluated at baseline and during up to 15 years after baseline.
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merete Haedersdal