CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

Status unconfirmed · Not applicable

Conditions studied: Atypical Endometrial Hyperplasia, Human Papillomavirus Infection, Stage 0 Cervical Cancer AJCC v7

In brief

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 biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.

Key facts

Study ID

NCT00892866

Run by

GOG Foundation

People needed

877

Starts

2009-04-13

Expected to finish

2025-05-31

Last updated by the study team

2024-05-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Olive View-University of California Los Angeles Medical Center — Sylmar, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
• Walter Knox Memorial Hospital — Emmett, Idaho, United States
• Idaho Urologic Institute-Meridian — Meridian, Idaho, United States
• Saint Alphonsus Medical Center-Nampa — Nampa, Idaho, United States
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
• Kootenai Cancer Clinic — Sandpoint, Idaho, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Good Samaritan Regional Health Center — Mount Vernon, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Michiana Hematology Oncology PC-Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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