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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02253719
Other study ID # SHCH-Cervical Screening-VIA
Secondary ID
Status Completed
Phase N/A
First received September 17, 2014
Last updated October 6, 2015
Start date October 2014
Est. completion date September 2015

Study information

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

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

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.

Locations

Country Name City State
Cambodia Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara Phnom Pehn

Sponsors (1)

Lead Sponsor Collaborator
Sihanouk Hospital Center of HOPE

Country where clinical trial is conducted

Cambodia, 

Outcome

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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