Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients

Study Overview
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Brief Summary
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Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic immunosuppression in these patients, there is an increasing focus on human papillomavirus (HPV) related cancers. The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical precancerous lesions among RTRs. Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal transplant recipients, together with identification of factors that play a role for development of anal and cervical precancerous lesions, is important for the possibility of early detection and treatment to prevent progression to ano-genital cancers. Cervical cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN), whereas high-resolution anoscopy is a newer modality for the detection of anal intra-epithelial neoplasia (AIN). International guidelines recommend annually screening against cervical cancer for female renal transplant recipients, but currently no recommendation exists on screening against anal cancer. Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal transplant recipients and an immunocompetent control group. Furthermore to identify factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.

Official Title
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Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients

Conditions
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Anogenital Dysplasia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Case group: Renal transplant recipients men and women ≥ 18 years of age ≥ 6 months posttransplantation Stabile immunosuppressive regime No signs of acute rejection og the transplant Control group: 1. Health men and women ≥18years of age from the Nevus clinic, Laser clinic and non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen Exclusion Criteria: Case group: Other known immunosuppression Both case- og control group: Previous HPV vaccination Previous total hysterectomy Inflammatory bowel disease HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>250 Renal Transplant Recipients; 125 women and 125 men | |
| Control group<br>250 healthy controls; 125 women and 125 men | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ano-genital HPV infection, dysplasia and warts | Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts | 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for the development of ano-genital dysplasia and warts | Identifying factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables. | 18 month |