Determine the following:1) What is thé main harbouring site of HPV in men ?2) What is the golden standard for male HPV screening ?3) What is the main HPV genotype in men ?4) Is there a HPV genotype specific anotomical site in men?
ID
Source
Brief title
Condition
- Other condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Health condition
Virale infectie thv het uro-genitaal
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) What is the main harbouring site for HPV in men?
2) What is the golden standard method for male HPV screening?
3) Which HPV-genotype is most frequently found in men ?
4) Is there a HPV genotype specific anotomical site in men?
Secondary outcome
1) Is the HPV-genotype found in men the same genotype as found in the endo-/
ecto cervical lesions of their partner?
(only for group 1, not for the control group)
Background summary
Human Papilloma Virus (HPV) is a sexually transmitted infection (SOI).
Genotypes 6 and 11 causes benign, still bothersome, lesions such as condylomata
accuminata. The high-risk-types (16, 18, 31, 45) causes malign lesions in the
anogenital region. Within 5 years after starting having sexual intercourse 80%
of the people has had an asymptomatic HPV-infection. We can presume that after
some time 100% of the sexually active part of the population has been infected
with HPV at some point in their life. About HPV and women is known a lot since
HPV is a causal co-factor for cervical carcinoma. Since HPV is a SOI, also men
are infected. About HPV and men is less known, since the prevalence of
HPV-related malignancies in men (penile cancer, anogenital cancer) is much
lower then in women. Probably this is due to the histological differences in
the epithelial coating of the lower urogenital tract in both genders.
Whe don't know yet how and if we have to treat HPV-infected males. Since they
can be a longterm carrier of the virus they can re-infect their partner.
The usefulness of male HPV-screening is still under discussion, but at the same
time this discussion is the relevance of this study.
Following problems rise:
1) What is thé harbouring site of HPV in men ?
2) Are different HPV genotypes found in the different anatomical sites. (e.g.
in females HPV 16 is found in the ectocervix while HPV 18 and 45 are found in
the endocervix).
3) As a consequence of 1) what is the golden standard for male HPV screening.
4) Is there a genotype-specific prevalence of HVP in men?
Study objective
Determine the following:
1) What is thé main harbouring site of HPV in men ?
2) What is the golden standard for male HPV screening ?
3) What is the main HPV genotype in men ?
4) Is there a HPV genotype specific anotomical site in men?
Study design
Men with a high-risk-HPV-infection profile and a low-risk-HPV-infection profile
(control group) are asked to participate voluntarely.
Men with a CIN-positive partner are put in the high-risk-group. Men who
contact us concerning non-HPV-related complaints are put in the
low-risk-group.
They are asked to fill in a questionnaire, their medical history is taken, they
get a physicale examination. 4 anantomical sites are sampled: anus, glans,
corona glandis, meatus urethrae. They are asked to provide a urine- and a
sperm sample.
Study burden and risks
None, only an investment of time.
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Age between 18 - 50 years old
Understanding the investigation and it's consequences
Signing the informed consent
+ Being the partner of an HPV-positive female patient (CIN) (groep 1)
+ Not being the partner of an female partner with HPV-positive cervical lesion(control gruop)
Exclusion criteria
Younger then 18 years old, older then 50 years old
Not being able to understand the investigation
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 | NL13850.091.06 |