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Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects - NCT00937950-27514(Clinical Trial 366112)



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City:  Chapel Hill
State:  
NC
Zip Code: 27514
Conditions: Human Papillomavirus (HPV) Type 16/18 Infections - Papillomavirus Vaccines - Cervical Neoplasia
Purpose: This study is designed provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study visit (Visit 10, Month 48). This follow-up study will also be offered to subjects who were pregnant at their last NCT 00122681 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).
Study summary:
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 NCT 00122681 and who fulfils either of the following criteria: - displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48). or • was pregnant at her last visit of the NCT 00122681 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 NCT 00122681 study visit (Visit 10, Month 48). - A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT 00122681 exit colposcopy. - A subject for whom the cervical cytology results from the last NCT 00122681 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.
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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