The Organ Transplant Recipient HPV and Skin Cancer Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention.
- Кому может быть актуально
- Состояния в реестре: Solid Organ Transplant Recipient, Skin Cancer, Skin Dysplasia, HPV Infection. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое No intervention
The study is an observational study without intervention.
Первичные конечные точки
- Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls. [Срок оценки: Evaluated at baseline and month 12]
Вторичные конечные точки (10)
- Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls. [Срок оценки: Evaluated at baseline]
- Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs. [Срок оценки: Evaluated at baseline]
- Correlations between lifestyle factors, clinical factors and occurrence of oral HPV infection in female OTRs. [Срок оценки: Evaluated at baseline]
- Difference in prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared to immunocompetent controls. [Срок оценки: 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. [Срок оценки: Evaluated at baseline]
- Correlation between Vitamin D and prevalence of skin dysplasia and cancer in OTRs. [Срок оценки: Evaluated at baseline]
- Correlations between skin pigmentation, facial solar lentigines and prevalence of skin dysplasia and cancer in OTRs. [Срок оценки: Evaluated at baseline]
- Correlation between prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs. [Срок оценки: Evaluated at baseline]
- Correlations between history of herpes zoster, prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs. [Срок оценки: Evaluated at baseline]
- Difference in prevalence and incidence of skin cancer in female OTRs compared to immunocompetent controls. [Срок оценки: Evaluated at baseline and during up to 15 years after baseline.]
Критерии участия
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Дания · 3 центра
- Department of Dermatology, Bispebjerg Hospital — Copenhagen NV
- Department of Dermatology and Allergy, Herlev og Gentofte Hospital — Hellerup
- Department of Dermatology, Zealand University Hospital — Roskilde
Идентификаторы
NCT: NCT05284877 · HPV Skin Cancer OTR · Journal-nr.: H-21038387