Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT03195218
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 18 years and older;
2. Women with abnormal cervical cytology (atypical squamous cells of undetermined significance or more severe interpretations \[≥ASC-US\]) or positive high-risk HPV test on cervical samples. Additionally, 10% of the study population will consist of women with no change in cervical cytology and HPV test in order to check verification bias (see further explanations in "6.2. Sample calculation");
3. Women with intact cervix or previously submitted to LEEP (loop electrosurgical excision procedure), cone or cryotherapy, with the presence of the cervix;
4. Women of childbearing potential should have a negative urine or blood pregnancy test;
5. Ability to understand and willing to provide informed consent document.
Exclusion Criteria:
1. Women under 18 years old;
2. Women who have undergone hysterectomy with removal of the cervix;
3. Women with known allergy to proflavine or acriflavine;
4. Women who are pregnant or nursing at the time of enrollment;
5. Incapacitated women or in vulnerable situations or who are not willing to give consent;
6. Women who belong to the indigenous community.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03195218
Study Brief:
Protocol Section:
NCT03195218