Human Papillomavirus InfectionsNCT01717443
Genital HPV Infections Before and After Renal Transplantation
An observational study of Human Papillomavirus Infections, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Papillomavirus Infections
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of women above 18 years of age with end stage renal disease who are registered for renal transplantation
Who may be able to join
- Female sex;
- Age ≥ 18 years at start of the study;
- Eligible for renal transplantation;
- Operation at the Radboud University Nijmegen Medical Centre;
- Signed informed consent;
- Mentally capable to understand and comprehend the study and its implications;
- Sufficient knowledge of the Dutch language to read, fully understand and complete the Questionnaire.
Who cannot join
- Patient not willing to sign and/or return the informed consent form;
- Patient refusing additional treatment in case of abnormal findings at the first visit;
- Patient being pregnant, or within a period of 3 months after delivery;
- Patient being within a period of 3 months after miscarriage.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation
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.
Read the detailed description
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.
- Conditions
- Human Papillomavirus Infections
- Keywords
- Human Papillomavirus, Renal transplantation
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women, renal disease, transplantation | Women with end-stage renal disease, whose eligibility for renal transplantation is assessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months before and 6 months after renal transplantation
Secondary outcomes (2)
Incidence of genital HPV infection before and after renal transplantation
Measured: Assessed every 3 months for 2 years
Genotype of the HPV infection per time point
Measured: Assessed every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Responsible party
- Principal investigator, Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
- Investigators
- Joanne A de Hullu, MD, PhD, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717443
- Sponsor's protocol ID
- NL38266.091.11
- Status last verified
- Oct 2016
- First submitted
- 23 Aug 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation
- ClinicalTrials.gov ID
- NCT01717443
- Acronym / sponsor ID
- NL38266.091.11
- Conditions
- Human Papillomavirus Infections
- Keywords
- Human Papillomavirus, Renal transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- Feb 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women, renal disease, transplantation | – | –Women with end-stage renal disease, whose eligibility for renal transplantation is assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of women above 18 years of age with end stage renal disease who are registered for renal transplantation
Key inclusion criteria (7 listed)
- Female sex;
- Age ≥ 18 years at start of the study;
- Eligible for renal transplantation;
- Operation at the Radboud University Nijmegen Medical Centre;
- Signed informed consent;
Key exclusion criteria (4 listed)
- Patient not willing to sign and/or return the informed consent form;
- Patient refusing additional treatment in case of abnormal findings at the first visit;
- Patient being pregnant, or within a period of 3 months after delivery;
- Patient being within a period of 3 months after miscarriage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease
Time frame: 6 months before and 6 months after renal transplantation
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne A de Hullu, MD, PhD principal investigator
University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infections, run by University Medical Center Nijmegen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease (time frame: 6 months before and 6 months after renal transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.