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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).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

2022

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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]

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年8月5日

一次修了 (実際)

2014年1月20日

研究の完了 (実際)

2014年1月20日

試験登録日

最初に提出

2009年7月2日

QC基準を満たした最初の提出物

2009年7月9日

最初の投稿 (見積もり)

2009年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月29日

QC基準を満たした最後の更新が送信されました

2019年10月17日

最終確認日

2019年10月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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