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OpenTrials
Completed

NCT Number: NCT02253719

Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

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).

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Key information

Conditions

Cervical Neoplasia Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara

Phnom Pehn, Cambodia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cryotherapy, further biopsy, LEEP, surgery as indicated

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sihanouk Hospital Center of HOPE

Other

Registry information

Official study title

Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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