Anogenital Dysplasia Clinical Trial
Official title:
Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients
| Verified date | January 2018 |
| Source | Bispebjerg Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | September 6, 2017 |
| Est. primary completion date | September 6, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Dermato-venereology, Bispebjerg Hospital | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital | Danish Cancer Society |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |