이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2019년 10월 17일 업데이트: 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).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

2022

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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]

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2009년 8월 5일

기본 완료 (실제)

2014년 1월 20일

연구 완료 (실제)

2014년 1월 20일

연구 등록 날짜

최초 제출

2009년 7월 2일

QC 기준을 충족하는 최초 제출

2009년 7월 9일

처음 게시됨 (추정)

2009년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 17일

마지막으로 확인됨

2019년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Gynaecological follow-up에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in India

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다