The Organ Transplant Recipient HPV and Skin Cancer Study

Cervical Cancer Clinical Trial

Official title:

The Organ Transplant Recipient HPV and Skin Cancer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284877
• Other study ID #: HPV Skin Cancer OTR
• Secondary ID: Journal-nr.: H-2
• Status: Recruiting
• Start date: March 10, 2022
• Est. completion date: April 2027

Study information

• Verified date: March 2023
• Source: Bispebjerg Hospital
• Contact: Lene Rask
• Phone: +45 23359940
• Email: lene.rask.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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, 600 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.

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, 600 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• HPV Infection
• HPV-Related Malignancy
• Papillomavirus Infections
• Skin Cancer
• Skin Neoplasms

Intervention

Other:
• No intervention
The study is an observational study without intervention.

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Bispebjerg Hospital	Copenhagen NV	Region Hovedstaden
Denmark	Department of Dermatology and Allergy, Herlev og Gentofte Hospital	Hellerup	Region Hovedstaden
Denmark	Department of Dermatology, Zealand University Hospital	Roskilde	Region Sjælland

Sponsors (6)

Lead Sponsor	Collaborator
Merete Haedersdal	Danish Cancer Society, Herlev and Gentofte Hospital, Rigshospitalet, Denmark, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	Evaluated at baseline
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.