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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT01881659 |
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Date of registration:
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17/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cervical Cancer Screening With Human Papillomavirus Testing
ESTAMPA |
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Scientific title:
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Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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50000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01881659 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Bolivia
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Chile
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Colombia
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Costa Rica
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Honduras
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Mexico
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Paraguay
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Peru
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Uruguay
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Contacts
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Name:
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Rolando Herrero, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Agency for Research on Cancer (IARC) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 30-64 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff
- Physically able to have a pelvic exam
Exclusion Criteria:
- Reporting no previous sexual activity
- History of cervical cancer
- Previous treatment for cervical pre-cancer in the last six months
- Hysterectomy
- Plans to move out of the study area in the next 12 months
- Screened for cervical cancer in the last 12 months (depending on local regulations)
Age minimum:
30 Years
Age maximum:
64 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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CIN3
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Cervical Cancer
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CIN2
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Intervention(s)
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Other: HPV screening
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Primary Outcome(s)
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Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology
[Time Frame: Detected after initial HPV screening or at second screening round 18 months since entry]
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Secondary Outcome(s)
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Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology
[Time Frame: Detected after initial HPV screening or at second screening round 18 months since entry]
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Secondary ID(s)
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IEC 12-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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