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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00937950
First received: July 2, 2009
Last updated: August 14, 2014
Last verified: May 2014
  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
Infections, Papillomavirus
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

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 ]

Enrollment: 2028
Study Start Date: August 2009
Study Completion Date: January 2014
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33759
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96826
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
GSK Investigational Site
New York, New York, United States, 10029
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
New Bern, North Carolina, United States, 28562
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74105
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
GSK Investigational Site
Erie, Pennsylvania, United States, 16507
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Australia, New South Wales
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Tasmania
GSK Investigational Site
Hobart, Tasmania, Australia
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Parkville, Victoria, Australia, 3052
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Leuven, Belgium, 3000
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
GSK Investigational Site
Campinas, Brazil, 13083-970
GSK Investigational Site
Curitiba, Brazil, 80060-150
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Canada, Newfoundland and Labrador
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1E 2C2
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Quebec
GSK Investigational Site
Beauport, Quebec, Canada, G1E 7G9
GSK Investigational Site
Gatineau, Quebec, Canada, J8Y 6S8
GSK Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Finland
GSK Investigational Site
Helsinki, Finland, 00610
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Kouvola, Finland, 45100
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Lahti, Finland, 15110
GSK Investigational Site
Lappeenranta, Finland, 53100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20100
GSK Investigational Site
Vaasa, Finland, 65100
Germany
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76199
GSK Investigational Site
Ravensburg, Baden-Wuerttemberg, Germany, 88212
GSK Investigational Site
Rheinstetten, Baden-Wuerttemberg, Germany, 76287
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Frankfurt, Hessen, Germany, 60439
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30657
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Leipzig, Sachsen, Germany, 04279
GSK Investigational Site
Nordhausen, Thueringen, Germany, 99734
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 22159
GSK Investigational Site
Hamburg, Germany, 20246
Italy
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
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, 4027
GSK Investigational Site
Makati City, Philippines, 1231
GSK Investigational Site
Manila, Philippines, 1004
Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
L'Hospitalet de Llobregat, Spain, 08907
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 114
GSK Investigational Site
Taipei, Taiwan, 112
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10700
United Kingdom
GSK Investigational Site
Aberdeen, United Kingdom, AB25 7ZD
GSK Investigational Site
London, United Kingdom, EC1M 6BQ
GSK Investigational Site
Manchester, United Kingdom, M13 0JH
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: August 14, 2014
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

ClinicalTrials.gov processed this record on November 27, 2014