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

17 oktober 2019 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2022

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Westmead, New South Wales, Australië, 2145
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australië
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, Australië, 3053
        • GSK Investigational Site
      • Parkville, Victoria, Australië, 3052
        • GSK Investigational Site
    • Western Australia
      • Perth, Western Australia, Australië
        • GSK Investigational Site
  • België
      • Brussels, België, 1090
        • GSK Investigational Site
      • Edegem, België, 2650
        • GSK Investigational Site
      • Leuven, België, 3000
        • GSK Investigational Site
  • Brazilië
      • Campinas, Brazilië, 13083-970
        • GSK Investigational Site
      • Curitiba, Brazilië, 80060-150
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazilië, 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
  • Duitsland
      • Berlin, Duitsland, 13086
        • GSK Investigational Site
      • Berlin, Duitsland, 13125
        • GSK Investigational Site
      • Hamburg, Duitsland, 20246
        • GSK Investigational Site
      • Hamburg, Duitsland, 22159
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Karlsruhe, Baden-Wuerttemberg, Duitsland, 76199
        • GSK Investigational Site
      • Ravensburg, Baden-Wuerttemberg, Duitsland, 88212
        • GSK Investigational Site
      • Rheinstetten, Baden-Wuerttemberg, Duitsland, 76287
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Duitsland, 80637
        • GSK Investigational Site
      • Wuerzburg, Bayern, Duitsland, 97070
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Duitsland, 60439
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Duitsland, 30657
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Duitsland, 55116
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Duitsland, 04279
        • GSK Investigational Site
    • Thueringen
      • Nordhausen, Thueringen, Duitsland, 99734
        • GSK Investigational Site
  • Filippijnen
      • Cavite, Filippijnen
        • GSK Investigational Site
      • Laguna, Filippijnen
        • GSK Investigational Site
      • Las Pinas City, Filippijnen
        • GSK Investigational Site
      • Los Banos, Laguna, Filippijnen, 4027
        • GSK Investigational Site
      • Makati City, Filippijnen, 1231
        • GSK Investigational Site
      • Manila, Filippijnen, 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
  • Italië
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italië, 41100
        • GSK Investigational Site
  • Spanje
      • Barcelona, Spanje, 08035
        • GSK Investigational Site
      • L'Hospitalet de Llobregat, Spanje, 08907
        • GSK Investigational Site
      • Madrid, Spanje, 28040
        • GSK Investigational Site
      • Móstoles/Madrid, Spanje, 28935
        • 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
  • Verenigd Koninkrijk
      • Aberdeen, Verenigd Koninkrijk, AB25 7ZD
        • GSK Investigational Site
      • London, Verenigd Koninkrijk, EC1M 6BQ
        • GSK Investigational Site
      • Manchester, Verenigd Koninkrijk, M13 0JH
        • GSK Investigational Site
  • Verenigde Staten
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33759
        • GSK Investigational Site
      • Miami, Florida, Verenigde Staten, 33136
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52242
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Verenigde Staten, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Verenigde Staten, 40004
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68131
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87131
        • GSK Investigational Site
    • New York
      • New York, New York, Verenigde Staten, 10029
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • GSK Investigational Site
      • New Bern, North Carolina, Verenigde Staten, 28562
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74105
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Verenigde Staten, 16508
        • GSK Investigational Site
      • Erie, Pennsylvania, Verenigde Staten, 16507
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107
        • GSK Investigational Site
      • Pleasant Hills, Pennsylvania, Verenigde Staten, 15236
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, Verenigde Staten, 98801
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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]

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 augustus 2009

Primaire voltooiing (Werkelijk)

20 januari 2014

Studie voltooiing (Werkelijk)

20 januari 2014

Studieregistratiedata

Eerst ingediend

2 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2009

Eerst geplaatst (Schatting)

13 juli 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

17 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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