Last updated: 10/18/2019 12:10:13

Gynaecological follow-up of a subset of 580299/008 (NCT00122681) study subjects

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GSK study ID
112024
See study documents
Clinicaltrials.gov ID
NCT00937950
See results summary
EudraCT ID
2008-008124-33
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Gynaecological follow-up of a subset of 580299/008 study subjects
Trial description: This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48).
This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with HPV DNA in cervical samples by Hybrid Capture 2 test (HCII)

Timeframe: At Months 12, 24, 36, 48

Number of subjects with colposcopy referral and colposcopy adequacy

Timeframe: At Months 12, 24, 36, 48

Number of subjects with cytological abnormalities in cervical samples by ThinPrep PapTest

Timeframe: At Months 12, 24, 36, 48

Number of subjects with cervical biopsy results at Month 12

Timeframe: At Month 12

Number of subjects with cervical biopsy results at Month 24

Timeframe: At Month 24

Number of subjects with cervical biopsy results at Month 36

Timeframe: At Month 36

Number of subjects with cervical biopsy results at Month 48

Timeframe: At Month 48

Number of subjects with treatment referrals by treatment type at Month 12

Timeframe: At Month 12

Number of subjects with treatment referrals by treatment type at Month 24

Timeframe: At Month 24

Number of subjects with treatment referrals by treatment type at Month 36

Timeframe: At Month 36

Number of subjects with treatment referrals by treatment type at Month 48

Timeframe: At Month 48

Number of subjects with adverse events (AEs) or serious adverse events (SAEs) leading to withdrawal

Timeframe: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]

Number of subjects with any fatal SAEs, with any SAEs assessed as possibly related to study participation or to a concurrent GSK medication.

Timeframe: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]

Secondary outcomes:
Not applicable
Interventions:
  • Other: Gynaecological follow-up
    • Enrollment:
    2022
    Primary completion date:
    2014-20-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    August 2009 to January 2014
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Written informed consent obtained from the subject prior to enrolment.
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
    • A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).
    • A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Written informed consent obtained from the subject prior to enrolment.

      • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
      • A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria:
    • displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48). or
    • was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
    Exclusion criteria:

      A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).

      • A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
      • A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy. If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject’s first study visit will be deferred until condition is resolved according to investigator’s medical judgment.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aberdeen, United Kingdom, AB25 7ZD
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bangkok, Thailand, 10330
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10700
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-20-01
    Actual study completion date
    2014-20-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
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