Solid Organ Transplant RecipientNCT05284877
The Organ Transplant Recipient HPV and Skin Cancer Study
An observational study of Solid Organ Transplant Recipient and Skin Cancer, run by Merete Haedersdal at 3 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplant Recipient, Skin Cancer, Skin Dysplasia
- How many people
- 1,500 participants
- Where
- 3 sitesDenmark
- Study dates
- 10 Mar 2022to Mar 2043
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Show all 10Show fewer
- Able patients aged ≥18 years
- No known immunosuppressive therapy or -condition
- Patients who reside in Denmark
- Informed written consent obtained
Who cannot join
- Patients with concomitant bone marrow transplantation
- Full hysterectomy
- Full hysterectomy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Dermatology, Bispebjerg Hospital
Copenhagen NV, Capital Region, 2400
Merete Hædersdal, DMSc, MD, mhaedersdal@dadlnet.dk
Lene Rask, PhD, lene.rask.01@regionh.dk
- Recruiting
Department of Dermatology and Allergy, Herlev og Gentofte Hospital
Hellerup, Capital Region, 2900
Claus Zachariae, DMSc, MD, claus.zachariae@regionh.dk
- Recruiting
Department of Dermatology, Zealand University Hospital
Roskilde, Region Sjælland, 4000
Gabrielle Vinding, Ass. Professor, PhD, MD, gbj@regionsjaelland.dk
About this study
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.
Read more
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.
Read the detailed description
AIMS
The specific research objectives of this study are:
- To investigate the overall and type-specific prevalence, incidence and persistence of cervical HPV infection in OTRs compared to immunocompetent controls.
- To investigate the overall and type-specific prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
- To determine the role of lifestyle and clinical factors for the occurrence of cervical and oral HPV infection in female OTRs.
- To investigate the prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared with immunocompetent controls.
- To determine the role of lifestyle, clinical and organ transplantation-related factors for the prevalence and incidence of skin dysplasia in OTRs.
- 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
- Solid Organ Transplant Recipient, Skin Cancer, Skin Dysplasia, HPV Infection, Cervical Intraepithelial Neoplasia, Cervical Cancer
- Being tested
- No intervention
- Keywords
- Organ transplant recipient, Skin cancer, Skin dysplasia, Human papillomavirus, HPV-related dysplasia, HPV-related cancer, HPV
- Medical subject headings
- Skin Neoplasms, Papillomavirus Infections, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study is an observational study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Male organ transplant recipients | 300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas) Receives: Other: No intervention | |
| Female organ transplant recipients | 600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas) Receives: Other: No intervention | |
| Female immunocompetent controls | 600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated at baseline and month 12
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Evaluated at baseline and during up to 15 years after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start10 Mar 2022
- Primary completionMar 2028 (estimated)
- Study completionMar 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ Transplant RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Zealand University Hospital, Vejle Hospital, Herlev and Gentofte Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Hædersdal, DMSc, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284877
- Sponsor's protocol ID
- HPV Skin Cancer OTR
- Other IDs
- Journal-nr.: H-21038387
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided