The Organ Transplant Recipient HPV and Skin Cancer Study

March 27, 2025 updated by: Merete Haedersdal

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AIMS

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen NV, Region Hovedstaden, Denmark, 2400
      • Hellerup, Region Hovedstaden, Denmark, 2900
        • Recruiting
        • Department of Dermatology and Allergy, Herlev og Gentofte Hospital
        • Contact:
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Recruiting
        • Department of Dermatology, Zealand University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Female organ transplant recipients
600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Other: No intervention
The study is an observational study without intervention.
Female immunocompetent controls
600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments
Other: No intervention
The study is an observational study without intervention.
Male organ transplant recipients
300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Other: No intervention
The study is an observational study without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.
Time Frame: Evaluated at baseline and month 12
Number of women with cervical HPV infection measured by PCR test.
Evaluated at baseline and month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated 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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline and during up to 15 years after baseline.
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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline
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.
Time Frame: Evaluated at baseline and during up to 15 years after baseline.
Number of women with skin cancer from registries using registry linkage
Evaluated at baseline and during up to 15 years after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merete Haedersdal

Collaborators

Zealand University Hospital
Rigshospitalet, Denmark
Danish Cancer Society
Vejle Hospital
Herlev and Gentofte Hospital

Investigators

  • Principal Investigator: Merete Hædersdal, DMSc, MD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2043

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV Skin Cancer OTR
  • Journal-nr.: H-21038387 (Other Identifier: National Committee on Health Research Ethics (NVK; Denmark))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe