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

2019年10月17日 更新者：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).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

2022

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年8月5日

初级完成 (实际的)

2014年1月20日

研究完成 (实际的)

2014年1月20日

研究注册日期

首次提交

2009年7月2日

首先提交符合 QC 标准的

2009年7月9日

首次发布 (估计)

2009年7月13日

研究记录更新

最后更新发布 (实际的)

2019年10月29日

上次提交的符合 QC 标准的更新

2019年10月17日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

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

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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