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

17 de octubre de 2019 actualizado por: GlaxoSmithKline

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

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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2022

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 13086
        • GSK Investigational Site
      • Berlin, Alemania, 13125
        • GSK Investigational Site
      • Hamburg, Alemania, 20246
        • GSK Investigational Site
      • Hamburg, Alemania, 22159
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Karlsruhe, Baden-Wuerttemberg, Alemania, 76199
        • GSK Investigational Site
      • Ravensburg, Baden-Wuerttemberg, Alemania, 88212
        • GSK Investigational Site
      • Rheinstetten, Baden-Wuerttemberg, Alemania, 76287
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Alemania, 80637
        • GSK Investigational Site
      • Wuerzburg, Bayern, Alemania, 97070
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Alemania, 60439
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Alemania, 30657
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Alemania, 55116
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Alemania, 04279
        • GSK Investigational Site
    • Thueringen
      • Nordhausen, Thueringen, Alemania, 99734
        • GSK Investigational Site
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • GSK Investigational Site
      • Parkville, Victoria, Australia, 3052
        • GSK Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • GSK Investigational Site
  • Brasil
      • Campinas, Brasil, 13083-970
        • GSK Investigational Site
      • Curitiba, Brasil, 80060-150
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasil, 90035-003
        • GSK Investigational Site
  • Bélgica
      • Brussels, Bélgica, 1090
        • GSK Investigational Site
      • Edegem, Bélgica, 2650
        • GSK Investigational Site
      • Leuven, Bélgica, 3000
        • GSK Investigational Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2C8
        • GSK Investigational Site
    • British Columbia
      • Langley, British Columbia, Canadá, V3A 4H9
        • GSK Investigational Site
    • Nova Scotia
      • Truro, Nova Scotia, Canadá, B2N 1L2
        • GSK Investigational Site
    • Quebec
      • Beauport, Quebec, Canadá, G1E 7G9
        • GSK Investigational Site
      • Montreal, Quebec, Canadá, H2K 4L5
        • GSK Investigational Site
  • España
      • Barcelona, España, 08035
        • GSK Investigational Site
      • L'Hospitalet de Llobregat, España, 08907
        • GSK Investigational Site
      • Madrid, España, 28040
        • GSK Investigational Site
      • Móstoles/Madrid, España, 28935
        • GSK Investigational Site
  • Estados Unidos
    • Florida
      • Clearwater, Florida, Estados Unidos, 33759
        • GSK Investigational Site
      • Miami, Florida, Estados Unidos, 33136
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96826
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68131
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87131
        • GSK Investigational Site
    • New York
      • New York, New York, Estados Unidos, 10029
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27514
        • GSK Investigational Site
      • New Bern, North Carolina, Estados Unidos, 28562
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74105
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Estados Unidos, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16508
        • GSK Investigational Site
      • Erie, Pennsylvania, Estados Unidos, 16507
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • GSK Investigational Site
      • Pleasant Hills, Pennsylvania, Estados Unidos, 15236
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, Estados Unidos, 98801
        • GSK Investigational Site
  • Filipinas
      • Cavite, Filipinas
        • GSK Investigational Site
      • Laguna, Filipinas
        • GSK Investigational Site
      • Las Pinas City, Filipinas
        • GSK Investigational Site
      • Los Banos, Laguna, Filipinas, 4027
        • GSK Investigational Site
      • Makati City, Filipinas, 1231
        • GSK Investigational Site
      • Manila, Filipinas, 1004
        • GSK Investigational Site
  • Finlandia
      • Helsinki, Finlandia, 00610
        • GSK Investigational Site
      • Jyvaskyla, Finlandia, 40100
        • GSK Investigational Site
      • Kotka, Finlandia, 48100
        • GSK Investigational Site
      • Kouvola, Finlandia, 45100
        • GSK Investigational Site
      • Kuopio, Finlandia, 70100
        • GSK Investigational Site
      • Lahti, Finlandia, 15110
        • GSK Investigational Site
      • Lappeenranta, Finlandia, 53100
        • GSK Investigational Site
      • Mikkeli, Finlandia, 50100
        • GSK Investigational Site
      • Oulu, Finlandia, 90220
        • GSK Investigational Site
      • Pori, Finlandia, 28100
        • GSK Investigational Site
      • Rauma, Finlandia, 26100
        • GSK Investigational Site
      • Seinajoki, Finlandia, 60100
        • GSK Investigational Site
      • Tampere, Finlandia, 33100
        • GSK Investigational Site
      • Turku, Finlandia, 20100
        • GSK Investigational Site
      • Vaasa, Finlandia, 65100
        • GSK Investigational Site
  • Italia
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italia, 41100
        • GSK Investigational Site
  • Reino Unido
      • Aberdeen, Reino Unido, AB25 7ZD
        • GSK Investigational Site
      • London, Reino Unido, EC1M 6BQ
        • GSK Investigational Site
      • Manchester, Reino Unido, M13 0JH
        • GSK Investigational Site
  • Tailandia
      • Bangkok, Tailandia, 10400
        • GSK Investigational Site
      • Bangkok, Tailandia, 10330
        • GSK Investigational Site
      • Bangkok, Tailandia, 10700
        • GSK Investigational Site
  • Taiwán
      • Taipei, Taiwán, 100
        • GSK Investigational Site
      • Taipei, Taiwán, 112
        • GSK Investigational Site
      • Taipei, Taiwán, 114
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: HPV-052 study subjects Group
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Periodo de tiempo: At Months 12, 24, 36, 48

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
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Periodo de tiempo: At Months 12, 24, 36, 48
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
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Periodo de tiempo: At Months 12, 24, 36, 48

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
Number of Subjects With Cervical Biopsy Results at Month 12
Periodo de tiempo: 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
Number of Subjects With Cervical Biopsy Results at Month 24
Periodo de tiempo: 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
Number of Subjects With Cervical Biopsy Results at Month 36
Periodo de tiempo: 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
Number of Subjects With Cervical Biopsy Results at Month 48
Periodo de tiempo: 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
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Periodo de tiempo: 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
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Periodo de tiempo: 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
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Periodo de tiempo: 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
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Periodo de tiempo: 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
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal
Periodo de tiempo: 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]
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]
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.
Periodo de tiempo: 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]
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]

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de agosto de 2009

Finalización primaria (Actual)

20 de enero de 2014

Finalización del estudio (Actual)

20 de enero de 2014

Fechas de registro del estudio

Enviado por primera vez

2 de julio de 2009

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2009

Publicado por primera vez (Estimar)

13 de julio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de octubre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

17 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 112024
  • 2008-008124-33 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

IPD for this study is available via the Clinical Study Data Request site.

Marco de tiempo para compartir IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Criterios de acceso compartido de IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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