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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive women | 500 HIV women will be recruited from the hospital's current patient base as well as the community |
| |
| HIV negative women | 500 HIV women will be recruited from the hospital's current patient base as well as the community |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment of HIV negative women who screen as positive |
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Inclusion Criteria:
Exclusion Criteria:
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The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.
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| Name | Affiliation | Role |
|---|---|---|
| Thay Sovanarra, MD | Sihanouk Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara | Phnom Pehn | Cambodia |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |