Cervical Cancer Clinical Trial
Official title:
Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
Verified date | October 2015 |
Source | Sihanouk Hospital Center of HOPE |
Contact | n/a |
Is FDA regulated | No |
Health authority | Cambodia: Ministry of Health |
Study type | Observational |
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).
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 49 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Cambodia | Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara | Phnom Pehn |
Lead Sponsor | Collaborator |
---|---|
Sihanouk Hospital Center of HOPE |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of cervical neoplasia in HIV positive women | 500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid | up to 12 months | No |
Primary | Prevalence of cervical neoplasia in HIV negative women | 500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid | up to 12 months | No |
Secondary | Treatment of HIV positive women who screen as positive | 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. | up to 12 months | No |
Secondary | Treatment of HIV negative women who screen as positive | 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. | up to 12 months | No |
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