To study the (high-risk) HPV-infection prevalence and genotype in a cohort of female renal transplant recipients in order to offer adequate follow up for the patients who are infected with high-risk HPV.
ID
Source
Brief title
Condition
- Female reproductive tract infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the prevalence of HPV infections and the
distribution of different HPV genotypes in our immunocompromised cohort.
Secondary outcome
Secondary endpoints are the prevalence of abnormal PAP smears and of cervical
pathology as diagnosed by gynaecological examination and colposcopy.
Other study parameters:
Population characteristics (sociodemographic features, medical data and
information regarding sexual behaviour) and experiences of the self-sampling
will be evaluated as well. Moreover, we will compare sociodemographic and
medical data of the non-responders (i.e. age, marital status and duration of
immunosuppression which will retrospectively be collected from the medical
charts of these patients) with corresponding data of the responders.
Background summary
Each year about 800 renal transplantations are performed in the Netherlands.
The current immunosuppressive strategies have led to a 1-year patient and graft
survival of more than 90%. This high survival rate urges to pay increasing
attention to the development of (pre)malignancies as a long-term side effect of
immunosuppressive medication. Renal transplant recipients have a significantly
increased risk to develop malignancies of the lower anogenital tract, e.g.
cervix, vulva and anus. These malignancies are among the most common
malignancies in renal transplant recipients. The carcinogenic role of human
papillomavirus (HPV) in cancer of the lower genital tract is clear, but it is
largely unknown whether the prevalence and genotypes of HPV change during
immunosuppression. The results of this project will provide useful information
with respect to HPV infections that could also be applicable to other
immunocompromised patients. Moreover, the results of this study will enable us
to gain more evidence for the usefulness of HPV vaccination for patients on the
waiting list for transplantation in order to prevent the development of lower
genital tract malignancy in immunocompromised patients.
Study objective
To study the (high-risk) HPV-infection prevalence and genotype in a cohort of
female renal transplant recipients in order to offer adequate follow up for the
patients who are infected with high-risk HPV.
Study design
Observational cohort study
Study burden and risks
Patients are asked to fill in one questionnaire and to perform one
cervico-vaginal self sample in the privacy at home. In case of being high-risk
HPV positive, the patient will be advised to visit the outpatient clinic of
Obstetrics & Gynaecology of the RUNMC for a PAP smear. In case of an abnormal
PAP smear, the patient will be advised to have further gynaecological
examination and colposcopy.
There are no risks to self-sampling when performed as explained in the supplied
instruction forms.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• Female sex
• Received a renal transplantation at the RUNMC in the period 1968 - 2008
• Age >= 18 years at start of the study
Exclusion criteria
• Patients not willing to sign and/or return the informed consent form
• Patient is pregnant, or within a period of 3 months after delivery
• Patient is within a period of 3 months after miscarriage
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36012.091.11 |