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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01190176
Registration number
NCT01190176
Ethics application status
Date submitted
26/08/2010
Date registered
27/08/2010
Date last updated
30/10/2019
Titles & IDs
Public title
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
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Scientific title
Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
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Secondary ID [1]
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2009-017282-35
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Secondary ID [2]
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113617
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Gynaecological follow-up
Other interventions - Cervarix
Other interventions - Placebo control
Experimental: HPV-062 study subjects Group - HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
Treatment: Surgery: Gynaecological follow-up
Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.
Other interventions: Cervarix
Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
Other interventions: Placebo control
Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
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Assessment method [1]
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Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading =ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading =LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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Timepoint [1]
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At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [2]
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Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
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Assessment method [2]
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Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading =ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading =LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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Timepoint [2]
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At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [3]
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Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
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Assessment method [3]
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Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading =ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading =LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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Timepoint [3]
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At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [4]
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Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
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Assessment method [4]
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Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading =ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading =LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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Timepoint [4]
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At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [5]
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Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
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Assessment method [5]
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Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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Timepoint [5]
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At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [6]
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Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
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Assessment method [6]
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Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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Timepoint [6]
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At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [7]
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Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
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Assessment method [7]
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Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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Timepoint [7]
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At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [8]
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Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
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Assessment method [8]
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Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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Timepoint [8]
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At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [9]
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Number of Subjects With Referral to Colposcopy at Month 12
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Assessment method [9]
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Timepoint [9]
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At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [10]
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Number of Subjects With Referral to Colposcopy at Month 24
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Assessment method [10]
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Timepoint [10]
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At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [11]
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Number of Subjects With Referral to Colposcopy at Month 36
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Assessment method [11]
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Timepoint [11]
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At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [12]
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Number of Subjects With Referral to Colposcopy at Month 48
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Assessment method [12]
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Detection was done on all subjects irrespective of their baseline HPV DNA status.
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Timepoint [12]
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At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [13]
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Number of Subjects With Referral to Treatment at Month 12
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Assessment method [13]
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If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
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Timepoint [13]
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At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [14]
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Number of Subjects With Referral to Treatment at Month 24
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Assessment method [14]
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If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
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Timepoint [14]
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At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [15]
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Number of Subjects With Referral to Treatment at Month 36
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Assessment method [15]
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If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
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Timepoint [15]
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At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Primary outcome [16]
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Number of Subjects With Referral to Treatment at Month 48
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Assessment method [16]
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If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
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Timepoint [16]
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At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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Eligibility
Key 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.
- A subject previously enrolled in the study NCT00294047 and who fulfils either of the
following criteria:
- displayed normal cervical cytology but tested positive for oncogenic HPV
infection at her concluding NCT00294047 study visit
- was pregnant so that no cervical sample could be collected at her concluding
NCT00294047 study visit
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Minimum age
28
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- A subject who at the NCT00294047 concluding study visit displayed normal cervical
cytology and who was negative for oncogenic HPV infection at that visit.
- A subject who at the NCT00294047 concluding study visit had a cervical lesion at that
visit or who had a cervical lesion that required treatment at her NCT00294047 exit
colposcopy.
- A subject for whom the cervical cytology results from the concluding NCT00294047 study
visit were unavailable for reasons other than pregnancy.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/09/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/09/2017
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Sample size
Target
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Accrual to date
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Final
34
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Iowa
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
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United States of America
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State/province [3]
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Washington
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Country [4]
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Canada
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State/province [4]
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Alberta
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Country [5]
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Canada
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State/province [5]
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British Columbia
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Country [6]
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Canada
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State/province [6]
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Nova Scotia
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Country [7]
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Canada
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State/province [7]
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Quebec
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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Netherlands
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State/province [9]
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Rotterdam
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Country [10]
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Portugal
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State/province [10]
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Almada
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Country [11]
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Portugal
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State/province [11]
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Coimbra
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Country [12]
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Portugal
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State/province [12]
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Lisboa
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Country [13]
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Portugal
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State/province [13]
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Setúbal
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Country [14]
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Russian Federation
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State/province [14]
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Moscow
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Country [15]
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Russian Federation
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State/province [15]
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Sankt-Petersburg
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Country [16]
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Singapore
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State/province [16]
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Singapore
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Country [17]
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United Kingdom
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State/province [17]
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London
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Country [18]
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United Kingdom
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State/province [18]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is intended to provide up to a maximum of four years of annual oncogenic human
papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study
subjects who displayed normal cervical cytology but tested positive for oncogenic HPV
infection at their concluding NCT00294047 study visit.
Women who were pregnant at their concluding NCT00294047 study visit may also be included in
this study, as no cervical sample could be collected at that visit.
The objectives and outcome measures of the primary phase (NCT00294047) are presented in a
separate protocol posting.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01190176
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01190176
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