Clinical trial · Interventional
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix | Biological | — | UNRESOLVED |
| Gynaecological follow-up | Procedure | — | UNRESOLVED |
| Placebo control | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV-062 study subjects Group
- description
- 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.
- interventionNames
- Procedure: Gynaecological follow-up
- Biological: Cervarix
- Biological: Placebo control
Primary outcomes (16)
- measure
- Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
- timeFrame
- At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
Show eligibility criteria text
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 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.
References
Publications (0)
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