Last updated: 10/18/2019 12:10:13
Gynaecological follow-up of a subset of 580299/008 (NCT00122681) study subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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:
- 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.
Written informed consent obtained from the subject prior to enrolment.
Exclusion criteria:
- 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.
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).
Trial location(s)
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33759
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16507
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30657
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96826
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76199
Status
Study Complete
Location
GSK Investigational Site
L'Hospitalet de Llobregat, Spain, 08907
Status
Study Complete
Location
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
New Bern, North Carolina, United States, 28562
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Nordhausen, Thueringen, Germany, 99734
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Status
Study Complete
Location
GSK Investigational Site
Ravensburg, Baden-Wuerttemberg, Germany, 88212
Status
Study Complete
Location
GSK Investigational Site
Rheinstetten, Baden-Wuerttemberg, Germany, 76287
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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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