The Organ Transplant Recipient HPV and Skin Cancer Study

NCT05284877 | Recruiting

• 2 other identifiers: HPV Skin Cancer OTRJournal-nr.: H-21038387
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Solid Organ Transplant Recipient; Skin Cancer; Skin Dysplasia; HPV Infection; Cervical Intraepithelial Neoplasia; Cervical Cancer; HPV-Related Malignancy

Keywords

Organ transplant recipient; Skin cancer; Skin dysplasia; Human papillomavirus; HPV-related dysplasia; HPV-related cancer; HPV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.

  Evaluated at baseline

• Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs.

  Evaluated at baseline

• Correlations between lifestyle factors, clinical factors and occurrence of oral HPV infection in female OTRs.

  Evaluated at baseline

• Difference in prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared to immunocompetent controls.

  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.

  Evaluated at baseline

Study Arms (3)

Male organ transplant recipients

300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)

Other: No intervention

Female organ transplant recipients

600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)

Other: No intervention

Female immunocompetent controls

600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments

Other: No intervention

Interventions

No intervention OTHER

The study is an observational study without intervention.

Female immunocompetent controls; Female organ transplant recipients; Male organ transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Patients with concomitant bone marrow transplantation
• Full hysterectomy
• Able patients aged ≥18 years
• No known immunosuppressive therapy or -condition
• Patients who reside in Denmark
• Informed written consent obtained
• \- Full hysterectomy

Sponsors & Collaborators

• Merete Haedersdal: lead
• Danish Cancer Society: collaborator
• Zealand University Hospital: collaborator
• Vejle Hospital: collaborator
• Herlev and Gentofte Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (3)

Department of Dermatology, Bispebjerg Hospital

Copenhagen NV, Capital Region, 2400, Denmark

RECRUITING

Department of Dermatology and Allergy, Herlev og Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

Department of Dermatology, Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Skin Neoplasms; Papillomavirus Infections; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms

Study Officials

• Merete Hædersdal, DMSc, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lene Rask

CONTACT

+45 23359940; lene.rask.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: March 10, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2043
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

DK (3)