An observational study in Human Papillomavirus Infections, sponsored by University Medical Center Nijmegen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by University Medical Center Nijmegen · Observational
The purpose of this study is to examine the prevalence, incidence and genotype of anogenital HPV infections in women before and after renal transplantation. With this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.
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 medical specialists to pay increasing attention to the long-term side effects of immunosuppressive medication, such as virus-associated cancers. An example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies are among the most common malignancies in renal transplant recipients (RTRs). The incidence of hrHPV-related cervical and vulvar malignancies is increased up to a 100-fold in RTRs compared to the general population. There is limited literature on the exact behaviour of HPV infection related anogenital (pre)malignancies in RTRs. A part of these (pre)malignancies are probably already present at the time of transplantation while others develop in the years after transplantation. With gynaecological examination the investigators can diagnose anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence before transplantation. Knowledge about HPV status before and after transplantation gives insight in the natural course of the HPV infection in this group of patients and with this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's enrollment of 65 is below the median of 490 across 157 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of women above 18 years of age with end stage renal disease who are registered for renal transplantation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with end-stage renal disease, whose eligibility for renal transplantation is assessed
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease
The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.
Time frame: 6 months before and 6 months after renal transplantation
Incidence of genital HPV infection before and after renal transplantation
Time frame: Assessed every 3 months for 2 years
Genotype of the HPV infection per time point
Time frame: Assessed every 3 months for 2 years
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Nijmegen