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

17 октября 2019 г. обновлено: 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).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

2022

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: 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.
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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]

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

GlaxoSmithKline

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

5 августа 2009 г.

Первичное завершение (Действительный)

20 января 2014 г.

Завершение исследования (Действительный)

20 января 2014 г.

Даты регистрации исследования

Первый отправленный

2 июля 2009 г.

Впервые представлено, что соответствует критериям контроля качества

9 июля 2009 г.

Первый опубликованный (Оценивать)

13 июля 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 октября 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 октября 2019 г.

Последняя проверка

1 октября 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Сроки обмена IPD

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

Критерии совместного доступа к 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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • КСО

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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