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Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

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ClinicalTrials.gov Identifier: NCT02253719
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Sihanouk Hospital Center of HOPE

Brief Summary:
The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).

Condition or disease Intervention/treatment
Cervical Neoplasia Cervical Cancer Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HIV positive women
500 HIV women will be recruited from the hospital's current patient base as well as the community
Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated
These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.

HIV negative women
500 HIV women will be recruited from the hospital's current patient base as well as the community
Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated
These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.




Primary Outcome Measures :
  1. Prevalence of cervical neoplasia in HIV positive women [ Time Frame: up to 12 months ]
    500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid

  2. Prevalence of cervical neoplasia in HIV negative women [ Time Frame: up to 12 months ]
    500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid


Secondary Outcome Measures :
  1. Treatment of HIV positive women who screen as positive [ Time Frame: up to 12 months ]
    Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.

  2. Treatment of HIV negative women who screen as positive [ Time Frame: up to 12 months ]
    Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.



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Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.
Criteria

Inclusion Criteria:

  • female, age 30-49, able to give informed consent

Exclusion Criteria:

  • pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253719


Locations
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Cambodia
Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara
Phnom Pehn, Cambodia
Sponsors and Collaborators
Sihanouk Hospital Center of HOPE
Investigators
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Principal Investigator: Thay Sovanarra, MD Sihanouk Hospital

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Responsible Party: Sihanouk Hospital Center of HOPE
ClinicalTrials.gov Identifier: NCT02253719     History of Changes
Other Study ID Numbers: SHCH-Cervical Screening-VIA
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Sihanouk Hospital Center of HOPE:
cervical neoplasia
cervical cancer'
visual inspection acetic acid
cryotherapy

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Acetic Acid
Anti-Bacterial Agents
Anti-Infective Agents