Cervical NeoplasiaNCT02253719
Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia
An observational study of Cervical Neoplasia and Cervical Cancer, run by Sihanouk Hospital Center of HOPE at 1 site in Cambodia.
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. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Neoplasia, Cervical Cancer
- What is being tested?
- cryotherapy, further biopsy, LEEP, surgery as indicated
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteCambodia
- Study dates
- Oct 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.
Who may be able to join
- female, age 30-49, able to give informed consent
Who cannot join
- pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
Trial locations and contacts
1 site in 1 country.
Cambodia1 site
Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara
Phnom Pehn
About this study
Official title: Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
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).
- Conditions
- Cervical Neoplasia, Cervical Cancer
- Being tested
- cryotherapy, further biopsy, LEEP, surgery as indicated
- Keywords
- cervical neoplasia, cervical cancer', visual inspection acetic acid, cryotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy, further biopsy, LEEP, surgery as indicatedProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive women | 500 HIV women will be recruited from the hospital's current patient base as well as the community Receives: Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated | |
| HIV negative women | 500 HIV women will be recruited from the hospital's current patient base as well as the community Receives: Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cervical neoplasia in HIV positive women
500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid
Measured: 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
Measured: up to 12 months
Secondary outcomes (2)
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.
Measured: up to 12 months
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihanouk Hospital Center of HOPE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thay Sovanarra, MD, Principal investigator, Sihanouk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253719
- Sponsor's protocol ID
- SHCH-Cervical Screening-VIA
- Status last verified
- Oct 2015
- First submitted
- 17 Sep 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid
- ClinicalTrials.gov ID
- NCT02253719
- Acronym / sponsor ID
- SHCH-Cervical Screening-VIA
- Conditions
- Cervical Neoplasia, Cervical Cancer
- Keywords
- cervical neoplasia, cervical cancer', visual inspection acetic acid, cryotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sihanouk Hospital Center of HOPEUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive women | – | Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated500 HIV women will be recruited from the hospital's current patient base as well as the community |
| HIV negative women | – | Procedure: cryotherapy, further biopsy, LEEP, surgery as indicated500 HIV women will be recruited from the hospital's current patient base as well as the community |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The 1000 women will be recruited from the current patient base of Sihanouk hospital and the surrounding community.
Key inclusion criteria (1 listed)
- female, age 30-49, able to give informed consent
Key exclusion criteria (1 listed)
- pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapy, further biopsy, LEEP, surgery as indicatedThese 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. | Procedure or surgery | HIV negative women, HIV positive women |
Primary outcome
Prevalence of cervical neoplasia in HIV positive women
Time frame: up to 12 months
500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid
Prevalence of cervical neoplasia in HIV negative women
Time frame: up to 12 months
500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid
2 secondary outcomes
Treatment of HIV positive women who screen as positive
Time frame: up to 12 months
Treatment of HIV negative women who screen as positive
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thay Sovanarra, MD principal investigator
Sihanouk Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neoplasia and Cervical Cancer, run by Sihanouk Hospital Center of HOPE at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cervical neoplasia in HIV positive women (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.