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

17. oktober 2019 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2022

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Belgia
      • Brussels, Belgia, 1090
        • GSK Investigational Site
      • Edegem, Belgia, 2650
        • GSK Investigational Site
      • Leuven, Belgia, 3000
        • 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
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • GSK Investigational Site
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Quebec
      • Beauport, Quebec, Canada, G1E 7G9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2K 4L5
        • GSK Investigational Site
  • Filippinene
      • Cavite, Filippinene
        • GSK Investigational Site
      • Laguna, Filippinene
        • GSK Investigational Site
      • Las Pinas City, Filippinene
        • GSK Investigational Site
      • Los Banos, Laguna, Filippinene, 4027
        • GSK Investigational Site
      • Makati City, Filippinene, 1231
        • GSK Investigational Site
      • Manila, Filippinene, 1004
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00610
        • GSK Investigational Site
      • Jyvaskyla, Finland, 40100
        • GSK Investigational Site
      • Kotka, Finland, 48100
        • GSK Investigational Site
      • Kouvola, Finland, 45100
        • GSK Investigational Site
      • Kuopio, Finland, 70100
        • GSK Investigational Site
      • Lahti, Finland, 15110
        • GSK Investigational Site
      • Lappeenranta, Finland, 53100
        • GSK Investigational Site
      • Mikkeli, Finland, 50100
        • GSK Investigational Site
      • Oulu, Finland, 90220
        • GSK Investigational Site
      • Pori, Finland, 28100
        • GSK Investigational Site
      • Rauma, Finland, 26100
        • GSK Investigational Site
      • Seinajoki, Finland, 60100
        • GSK Investigational Site
      • Tampere, Finland, 33100
        • GSK Investigational Site
      • Turku, Finland, 20100
        • GSK Investigational Site
      • Vaasa, Finland, 65100
        • GSK Investigational Site
  • Forente stater
    • Florida
      • Clearwater, Florida, Forente stater, 33759
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33136
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96826
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Forente stater, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Forente stater, 40004
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68131
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87131
        • GSK Investigational Site
    • New York
      • New York, New York, Forente stater, 10029
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27514
        • GSK Investigational Site
      • New Bern, North Carolina, Forente stater, 28562
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74105
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16508
        • GSK Investigational Site
      • Erie, Pennsylvania, Forente stater, 16507
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • GSK Investigational Site
      • Pleasant Hills, Pennsylvania, Forente stater, 15236
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, Forente stater, 98801
        • GSK Investigational Site
  • Italia
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italia, 41100
        • GSK Investigational Site
  • Spania
      • Barcelona, Spania, 08035
        • GSK Investigational Site
      • L'Hospitalet de Llobregat, Spania, 08907
        • GSK Investigational Site
      • Madrid, Spania, 28040
        • GSK Investigational Site
      • Móstoles/Madrid, Spania, 28935
        • GSK Investigational Site
  • Storbritannia
      • Aberdeen, Storbritannia, AB25 7ZD
        • GSK Investigational Site
      • London, Storbritannia, EC1M 6BQ
        • GSK Investigational Site
      • Manchester, Storbritannia, M13 0JH
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taipei, Taiwan, 114
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13086
        • GSK Investigational Site
      • Berlin, Tyskland, 13125
        • GSK Investigational Site
      • Hamburg, Tyskland, 20246
        • GSK Investigational Site
      • Hamburg, Tyskland, 22159
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Karlsruhe, Baden-Wuerttemberg, Tyskland, 76199
        • GSK Investigational Site
      • Ravensburg, Baden-Wuerttemberg, Tyskland, 88212
        • GSK Investigational Site
      • Rheinstetten, Baden-Wuerttemberg, Tyskland, 76287
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Tyskland, 80637
        • GSK Investigational Site
      • Wuerzburg, Bayern, Tyskland, 97070
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Tyskland, 60439
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30657
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Tyskland, 55116
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Tyskland, 04279
        • GSK Investigational Site
    • Thueringen
      • Nordhausen, Thueringen, Tyskland, 99734
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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]

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. august 2009

Primær fullføring (Faktiske)

20. januar 2014

Studiet fullført (Faktiske)

20. januar 2014

Datoer for studieregistrering

Først innsendt

2. juli 2009

Først innsendt som oppfylte QC-kriteriene

9. juli 2009

Først lagt ut (Anslag)

13. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere