Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253719
• Other study ID #: SHCH-Cervical Screening-VIA
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Neoplasia
• Uterine Cervical Neoplasms

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