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| ID | Type | Description | Link |
|---|---|---|---|
| Journal-nr.: H-21038387 | Other Identifier | National Committee on Health Research Ethics (NVK; Denmark) |
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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| Zealand University Hospital | OTHER |
| Vejle Hospital | OTHER |
| Herlev and Gentofte Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male organ transplant recipients | 300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas) |
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| Female organ transplant recipients | 600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas) |
| |
| Female immunocompetent controls | 600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | The study is an observational study without intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at baseline |
| Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs. |
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Inclusion Criteria for OTRs:
Exclusion Criteria for OTRs:
Inclusion Criteria for Control group:
Exclusion Criteria for Control group:
- Full hysterectomy
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lene Rask | Contact | +45 23359940 | lene.rask.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Merete Hædersdal, DMSc, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Bispebjerg Hospital | Recruiting | Copenhagen NV | Capital Region | 2400 | Denmark |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D030361 | Papillomavirus Infections |
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| Rigshospitalet, Denmark | OTHER |
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Whole blood samples from all OTRs at baseline and 6 months after the baseline visit.
Cervico-vaginal self-sample from all female OTRs and controls at baseline and 12 months after the baseline visit.
Oral mouthwash sample from all female OTRs and controls at baseline.
Lifestyle factors determined by questionnaire. Clinical factors from medical records. Number of women with cervical HPV infection measured by PCR test. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | Evaluated at baseline and during up to 15 years after baseline. |
| Department of Dermatology and Allergy, Herlev og Gentofte Hospital | Recruiting | Hellerup | Capital Region | 2900 | Denmark |
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| Department of Dermatology, Zealand University Hospital | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011230 | Precancerous Conditions |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |