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

Completed

• Conditions: Anogenital Dysplasia

• Registration Number: NCT03018327
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-07
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Primary Completion: 2017-09-06
• Study Completion: 2017-09-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Case group:

1. Renal transplant recipients men and women ≥ 18 years of age
2. ≥ 6 months posttransplantation
3. Stabile immunosuppressive regime
4. 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:

  1. Other known immunosuppression

     Both case- og control group:

  2. Previous HPV vaccination

  3. Previous total hysterectomy

  4. Inflammatory bowel disease

  5. HIV infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of ano-genital HPV infection, dysplasia and warts	18 month	Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts

Secondary Outcome Measures

Name	Time	Method
Risk factors for the development of ano-genital dysplasia and warts	18 month	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.

Trial Locations

Locations (1)

Department of Dermato-venereology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark