Summary

for females ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
Michael T. McHale

Description

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.

Official Title

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)

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Keywords

Atypical Endocervical Glandular Cell of Undetermined Significance Atypical Endometrial Hyperplasia Human Papillomavirus Infection Stage 0 Cervical Cancer AJCC v7 Uterine Cervical Neoplasms Hyperplasia Papillomavirus Infections Endometrial Hyperplasia Cervical Intraepithelial Neoplasia Cytology Specimen Collection Procedure Laboratory Biomarker Analysis Ancillary-Correlative (biomarkers in cervical cancer)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange California 92868 United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT00892866
Lead Scientist
Michael T. McHale
Study Type
Observational
Last Updated
May 4, 2018