Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Infections, Papillomavirus Clinical Trial

Official title:

Gynaecological Follow-up of a Subset of 580299/008 Study Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937950
• Other study ID #: 112024
• Secondary ID: 2008-008124-33
• Status: Completed
• Phase: Phase 3
• Start date: August 5, 2009
• Est. completion date: January 20, 2014

Study information

• Verified date: October 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2022
• Est. completion date: January 20, 2014
• Est. primary completion date: January 20, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

Other:
• Gynaecological follow-up
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Carlton	Victoria
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	Parkville	Victoria
Australia	GSK Investigational Site	Perth	Western Australia
Australia	GSK Investigational Site	Westmead	New South Wales
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Leuven
Brazil	GSK Investigational Site	Campinas
Brazil	GSK Investigational Site	Curitiba
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Canada	GSK Investigational Site	Beauport	Quebec
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jyvaskyla
Finland	GSK Investigational Site	Kotka
Finland	GSK Investigational Site	Kouvola
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Lappeenranta
Finland	GSK Investigational Site	Mikkeli
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Rauma
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vaasa
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Nordhausen	Thueringen
Germany	GSK Investigational Site	Ravensburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Rheinstetten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuerzburg	Bayern
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Philippines	GSK Investigational Site	Cavite
Philippines	GSK Investigational Site	Laguna
Philippines	GSK Investigational Site	Las Pinas City
Philippines	GSK Investigational Site	Los Banos, Laguna
Philippines	GSK Investigational Site	Makati City
Philippines	GSK Investigational Site	Manila
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	L'Hospitalet de Llobregat
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Móstoles/Madrid
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
United Kingdom	GSK Investigational Site	Aberdeen
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New Bern	North Carolina
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pleasant Hills	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Finland,  Germany,  Italy,  Philippines,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)	Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.; Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).	At Months 12, 24, 36, 48
Primary	Number of Subjects With Colposcopy Referral and Colposcopy Adequacy	Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of = atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of = low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.	At Months 12, 24, 36, 48
Primary	Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest	Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.; Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.	At Months 12, 24, 36, 48
Primary	Number of Subjects With Cervical Biopsy Results at Month 12	Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.; CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.; Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 12
Primary	Number of Subjects With Cervical Biopsy Results at Month 24	Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.; CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.; Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 24
Primary	Number of Subjects With Cervical Biopsy Results at Month 36	Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.; CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.; Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 36
Primary	Number of Subjects With Cervical Biopsy Results at Month 48	Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.; CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.; Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 48
Primary	Number of Subjects With Treatment Referrals by Treatment Type at Month 12	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.; The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 12
Primary	Number of Subjects With Treatment Referrals by Treatment Type at Month 24	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.; The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 24
Primary	Number of Subjects With Treatment Referrals by Treatment Type at Month 36	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.; The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 36
Primary	Number of Subjects With Treatment Referrals by Treatment Type at Month 48	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.; The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 48
Primary	Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	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]
Primary	Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.	SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.	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]

External Links

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