NCT00892866

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

Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients With a Cytologic Diagnosis of Atypical Glandular Cells (AGC)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 877 (estimated)
• Sponsor: GOG Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 provide the optimal diagnosis of significant cervical lesions in women in North America with a cytologic diagnosis of atypical glandular cells (AGC) and a positive test for high risk human papillomavirus (HPV). II. To examine high risk HPV, CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens to see which subset of markers can provide the optimal diagnosis of significant cervical lesions in women in Japan and Korea (with each country's cohort analyzed separately) with a cytologic diagnosis of AGC. SECONDARY OBJECTIVES: I. To determine whether the accuracy of diagnosis based on high risk HPV and expression of CA-IX, p16, Ki-67, and/or MCM2 varies with patient age at enrollment and country of enrollment. TERTIARY OBJECTIVES: I. To assess biomarker expression, loss of heterozygosity, and chromosome gains/losses in formalin-fixed, paraffin-embedded tissue from the highest grade or most abnormal lesion in women from North America, Japan, or Korea presenting with a cytologic diagnosis of AGC or with a cytologic/histologic diagnosis of adenocarcinoma in situ (AIS). II. To determine CA-IX, p16, Ki67, and MCM2 expression in LBC specimens to see which subset (or combination) of markers will provide higher sensitivity in the diagnosis of cervical adenocarcinoma in situ (AIS). OUTLINE: Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via immunohistochemistry (IHC) and for the presence of high risk HPV deoxyribonucleic acid (DNA) and HPV genotyping.

Conditions

• Atypical Endometrial Hyperplasia
• Human Papillomavirus Infection
• Stage 0 Cervical Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2009-04-13
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2009-05-05
• Last updated: 2024-05-03

Locations

163 sites across 3 countries: United States, Japan, South Korea