Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

NCT ID: NCT02253719

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Cervical Neoplasia Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV positive women

500 HIV women will be recruited from the hospital's current patient base as well as the community

cryotherapy, further biopsy, LEEP, surgery as indicated

Intervention Type 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.

HIV negative women

500 HIV women will be recruited from the hospital's current patient base as well as the community

cryotherapy, further biopsy, LEEP, surgery as indicated

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sihanouk Hospital Center of HOPE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thay Sovanarra, MD

Role: PRINCIPAL_INVESTIGATOR

Sihanouk Hospital

Locations

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

Phnom Pehn, , Cambodia

Site Status

Countries

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Cambodia

Other Identifiers

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SHCH-Cervical Screening-VIA

Identifier Type: -

Identifier Source: org_study_id

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