Status:
ACTIVE_NOT_RECRUITING
CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
Lead Sponsor:
GOG Foundation
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Atypical Endometrial Hyperplasia
Human Papillomavirus Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying ...
Detailed Description
PRIMARY OBJECTIVES: I. To examine CA-IX, p16, Ki-67, and mini-chromosome maintenance complex component 2 (MCM2) expression in liquid-based cytology (LBC) specimens to see which subset of markers can ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT00892866
Start Date
April 13 2009
End Date
May 31 2025
Last Update
May 3 2024
Active Locations (163)
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1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
4
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027