To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Reproductive neoplasms female malignant and unspecified
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV
DNA testing (Hybrid Capture® 2 test [HC2])
- Occurrence of cervical cytological abnormalities in cervical samples by
ThinPrep® PapTest
- Occurrence of referral to colposcopy
- Occurrence of referral to treatment
Secondary outcome
Not applicable
Background summary
Study subjects enrolled in the control arm of the HPV-015 study may have been
infected with the HPV types included in the vaccine during the study. All
subjects may have been exposed to other high-risk HPV types. The current study
will provide annual oncogenic HPV DNA testing and cervical cytology examination
for a subset of HPV-015 subjects who at their concluding HPV-015 study visit:
displayed normal cervical cytology but tested positive for oncogenic HPV
infection or were pregnant so that no cervical sample could be collected.
Study objective
To provide clinical management and, if required, treatment to subjects who at
their concluding HPV-015 study visit displayed normal cervical cytology but
tested positive for oncogenic HPV infection or who were pregnant at their
concluding visit of the HPV-015 study so that no cervical sample could be
collected.
Study design
A phase IIIb, open, multi-centre gynaecological extension study for the
follow-up of a subset of HPV-015 study subjects in Asian-Pacific, Europe,
Latin-America and North-America with approximately 1500 study subjects.
Annual gynaecological follow-up, oncogenic HPV DNA testing and cervical
cytology examination for a subset of HPV-015 subjects. Visits in month 12, 24,
36 and 48. Subjects will enter the study approximately one year after their
HPV-015 concluding study visit: Visit 9, Visit 11 or at the last study visit in
HPV-015 planned under protocol amendment 4.
Intervention
In the HPV-015 (104820) study the following groups were randomised:
One group randomised to HPV (HPV-16/18 L1/AS04) vaccination (0,5ml
intramuscular) in month 0, 1 en 6
One group randomised to conrol (Al(OH)3) vaccination (0,5ml intramuscular) in
month 0, 1 en 6
Study burden and risks
Study subjects will undergo annual gynaecological examination, collection of
cervical cytology samples and if applicable, colposcopy. These study procedures
are according to local medical practice and are performed by medical qualified
personnel. However, the procedures may cause adverse effects or inconvenience
to study subjects.
Rue De L'Institut 89
Rixensart B-1330
BE
Rue De L'Institut 89
Rixensart B-1330
BE
Listed location countries
Age
Inclusion criteria
- A subjects previously enrolled in the HPV-015 study
- A subject with normal cervical cytology but positive test result for oncogenic HPV infection at concluding HPV-015 study visit
- A subject that was pregnant so that no cervical sample could be collected at concluding HPV-015 study visit
Exclusion criteria
- A subject with normal cervical cytology and negative test result for oncogenic HPV infection at concluding HPV-015 study visit
- A subject with a cervical lesion or with a cervical lesion that required treatment at concluding HPV-015 study visit
- A subject for whom the cervical cytology results were unavailable for reasons other than pregnancy at concluding HPV-015 study visit
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2009-017282-35-NL |
| CCMO | NL33307.098.10 |