The Organ Transplant Recipient HPV and Skin Cancer Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Able patients aged ≥18 years

• No known immunosuppressive therapy or -condition

• Patients who reside in Denmark

• Informed written consent obtained

Locations
Other Locations
Denmark
Department of Dermatology, Bispebjerg Hospital
RECRUITING
Copenhagen Nv
Department of Dermatology and Allergy, Herlev og Gentofte Hospital
RECRUITING
Hellerup
Department of Dermatology, Zealand University Hospital
RECRUITING
Roskilde
Contact Information
Primary
Lene Rask
lene.rask.01@regionh.dk
+45 23359940
Time Frame
Start Date: 2022-03-10
Estimated Completion Date: 2043-03
Participants
Target number of participants: 1500
Treatments
Male organ transplant recipients
300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Female organ transplant recipients
600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)
Female immunocompetent controls
600 immunocompetent women without organ transplant or other immunosuppressive conditions/treatments
Sponsors
Leads: Merete Haedersdal
Collaborators: Zealand University Hospital, Herlev and Gentofte Hospital, Danish Cancer Society, Vejle Hospital, Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov