Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects - Full Text View

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).

Condition	Intervention	Phase
Human Papillomavirus (HPV) Type 16/18 Infections Cervical Neoplasia	Procedure: Gynaecological follow-up	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Gynaecological Follow-up of a Subset of 580299/008 Study Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
Evaluation of cervical cytological abnormalities in cervical samples [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
Occurrence of referral to colposcopy. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Evaluation of colposcopy outcomes and biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Occurrence of referrals to treatment. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Evaluation of local cervical therapy performed and treatment biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Occurrence of fatal SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Occurrence and intensity of SAEs assessed as possibly related to study participation. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Occurrence and intensity of SAEs assessed as possibly related to a concurrent GSK medication. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Withdrawals from the study due to AEs and SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single group NCT 00122681 study subjects who had normal cervical cytology but tested positive for oncogenic HPV at their final NCT 00122681 study visit (Visit 10 at Month 48) or were pregnant at their final NCT 00122681 study visit (Visit 10 at Month 48)	Procedure: Gynaecological follow-up Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937950

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Show 54 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00937950 History of Changes
Other Study ID Numbers:	112024
Study First Received:	July 2, 2009
Last Updated:	April 25, 2013
Health Authority:	Finland: Finnish Medicines Agency Spain: Agencia Española del Medicamento y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency Belgium: FAGG Mexico: Ministry of Health - Secretaria de Salud - Comisión de Autorización Sanitaria - Comisión Federal para la Protección cotnra riesgos de salud Canada: Biologics and Genetic Therapies Directorate (BGTD) Taiwan: Department of Health Thailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public health Brazil: ANVISA Philippines: Bureau of Food and Drugs Italy: Comitato Etico Provinciale di Modena, Policlinico di Modena Azienda Ospedaliera Germany: Paul-Ehrlich-Institut United States: Food and Drug Administration Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

HPV
Papillomavirus
Human papillomavirus
Cervical cancer
HPV vaccine

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013