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Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR2)

19. september 2014 opdateret af: Cynthia S Firnhaber, University of Witwatersrand, South Africa

To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.

Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.

A. PRIMARY AIMS (S.A.):

  1. To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
  2. To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
  3. To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.

SECONDARY AIMS:

1. To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.

3. To determine the cervical disease recurrence rates with cryotherapy and LLETZ.

4. To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

166

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2092
        • Helen Joseph Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women 18-65 years of age
  • Not menstruating (if menstruating, the patient can be screened at another date)
  • Able to sign consent
  • Able to follow the study protocol
  • HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
  • Participant with histology-proven CIN 2 or 3 disease

Exclusion Criteria:

  • Pregnant
  • Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
  • Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
  • Previous hysterectomy with removal of the cervix
  • Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk

  • Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:

    1. Lesion is greater than ≥75% cervix
    2. Lesion entering into the cervical canal and the complete lesion cannot be visualized
    3. Presence of abnormal vasculature
    4. Lesion bigger that the cryotherapy probe

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm B
LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
Procedure: LEEP
The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine.
Andre navne:
  • Loop Electric Excision Procedure
Eksperimentel: Arm A
Cryotherapy treatment of CIN 2/3 cervical lesions
Procedure: Cryotherapy
This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun
Andre navne:
  • This is a study using Freezing with a cryogun

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare efficacy of cryotherapy and LEEP
Tidsramme: 1 year
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The ability to use Human Papillomavirus as the measure of treatment success
Tidsramme: 1 year
To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
1 year
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women
Tidsramme: 1 month, 6 months and 12 months
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women by evaluating adverse events as measured by the Division of AIDS toxicity table 2004 (revised August 2010)
1 month, 6 months and 12 months
Describe factors associated with successful treatment of CIN 2/3
Tidsramme: 1 year
To describe HIV disease status (CD4, HIV viral load), demographics, tissue margins and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
1 year
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
Tidsramme: 6 months and 12 months
To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy
6 months and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Witwatersrand, South Africa

Efterforskere

  • Ledende efterforsker: Cynthia S Firnhaber, MD, University of Witwatersrand, South Africa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2010

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

6. november 2012

Først indsendt, der opfyldte QC-kriterier

6. november 2012

Først opslået (Skøn)

8. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZA.09.0265

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cervikal intraepitelial neoplasi

Kliniske forsøg med LEEP

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner