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:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00892866
Eligibility Criteria:
Inclusion Criteria:
* Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells \[AEC\], atypical endometrial cells \[AEmC\]) or a cytologic/histologic diagnosis of AIS documented within the last 6 months who can wait at least one week after the AGC or AIS diagnosis to have an LBC specimen (i.e., ThinPrep) collected and then receive any other intervention; acceptable time frame range is 4 days prior to registration to 7 days after registration
* Patients with positive HPV results who are willing to undergo a complete histologic examination of the uterus and cervix, including the cervical transformation zone, within 6 months of the AGC or AIS diagnosis (histologic examination includes a loop electrosurgical excision procedure \[LEEP\], loop excision of the transformation zone \[LETZ\], excisional cone biopsy, or hysterectomy)
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
* Patients who have had a hysterectomy
* History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
* Patients who have previously been treated, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer
* Patients who are known to be human immunodeficiency virus (HIV)-positive
* Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00892866
Study Brief:
Protocol Section:
NCT00892866