- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01723956
Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR2)
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.):
- 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.
- 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.
- 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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gauteng
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Johannesburg, Gauteng, Sud Africa, 2092
- Helen Joseph Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
- Lesion is greater than ≥75% cervix
- Lesion entering into the cervical canal and the complete lesion cannot be visualized
- Presence of abnormal vasculature
- Lesion bigger that the cryotherapy probe
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Arm B
LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
|
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.
Altri nomi:
|
Sperimentale: Arm A
Cryotherapy treatment of CIN 2/3 cervical lesions
|
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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Compare efficacy of cryotherapy and LEEP
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The ability to use Human Papillomavirus as the measure of treatment success
Lasso di tempo: 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
Lasso di tempo: 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)
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1 month, 6 months and 12 months
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Describe factors associated with successful treatment of CIN 2/3
Lasso di tempo: 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.
Lasso di tempo: 6 months and 12 months
|
To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy
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6 months and 12 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Cynthia S Firnhaber, MD, University of Witwatersrand, South Africa
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Malattie della cervice uterina
- Malattie uterine
- Condizioni precancerose
- Infezioni da HIV
- Carcinoma in situ
- Neoplasia intraepiteliale cervicale
- Sieropositività HIV
- Displasia cervicale uterina
Altri numeri di identificazione dello studio
- ZA.09.0265
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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