The Organ Transplant Recipient HPV and Skin Cancer Study
NCT ID: NCT05284877
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2022-03-10
2043-03-31
Brief Summary
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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.
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Detailed Description
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The specific research objectives of this study are:
1. To investigate the overall and type-specific prevalence, incidence and persistence of cervical HPV infection in OTRs compared to immunocompetent controls.
2. To investigate the overall and type-specific prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
3. To determine the role of lifestyle and clinical factors for the occurrence of cervical and oral HPV infection in female OTRs.
4. To investigate the prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared with immunocompetent controls.
5. To determine the role of lifestyle, clinical and organ transplantation-related factors for the prevalence and incidence of skin dysplasia in OTRs.
6. To investigate associations between skin dysplasia and prevalence of cervical HPV infection and VZV infection in OTRs.
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:
* At baseline: Questionnaire, dermatologic skin assessment, assessment of skin photodamage (only OTRs recruited from Bispebjerg Hospital), medical record information, cervico-vaginal HPV self-sample test (women only), oral sample for HPV test (women only), blood sample for future research, blood sample for vitamin D test (only OTRs recruited from Bispebjerg Hospital).
* After 6 months: New blood sample for vitamin D test (only OTRs recruited from Bispebjerg Hospital).
* After 12 months: New cervico-vaginal HPV self-sample test (women only).
The following data will be collected from female immunocompetent controls:
* At baseline: Questionnaire, cervico-vaginal HPV self-sample test, oral sample for HPV test.
* After 12 months: New cervico-vaginal HPV self-sample test.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Male organ transplant recipients
300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)
No intervention
The study is an observational study without intervention.
Female organ transplant recipients
600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)
No intervention
The study is an observational study without intervention.
Female immunocompetent controls
600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments
No intervention
The study is an observational study without intervention.
Interventions
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No intervention
The study is an observational study without intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Full hysterectomy
\- Full hysterectomy
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Zealand University Hospital
OTHER
Vejle Hospital
OTHER
Herlev and Gentofte Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Merete Haedersdal
OTHER
Responsible Party
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Merete Haedersdal
Principal investigator
Principal Investigators
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Merete Hædersdal, DMSc, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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Department of Dermatology, Bispebjerg Hospital
Copenhagen NV, Capital Region, Denmark
Department of Dermatology and Allergy, Herlev og Gentofte Hospital
Hellerup, Capital Region, Denmark
Department of Dermatology, Zealand University Hospital
Roskilde, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Journal-nr.: H-21038387
Identifier Type: OTHER
Identifier Source: secondary_id
HPV Skin Cancer OTR
Identifier Type: -
Identifier Source: org_study_id
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