Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia

Trial Information

Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia

OBJECTIVES:

- Evaluate the utility of MN protein, a novel tumor-associated antigen, as a potential
diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with
a cytologic diagnosis of atypical glandular cells of undetermined significance (AGUS).

- Measure the frequency and type of cervical pathology associated with the diagnosis of
AGUS in these patients.

- Determine whether the presence of a high-risk type of human papilloma virus (HPV) in a
ThinPrep cervical cell specimen predicts the presence of cervical glandular and/or
squamous cell neoplasia in these patients.

- Determine the relationship between MN antigen expression and the presence of high-risk
HPV in these patients.

OUTLINE: This is a multicenter study.

Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the
time of direct colposcopic examination. Patients then undergo a cone biopsy of the cervix
using loop electrosurgical excision procedure with an endocervical curettage, an excisional
cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy.
Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy
also undergo endometrial biopsy or curettage. The Pap smear specimen is analyzed to
determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of
high-risk human papilloma virus and to determine MN antigen and other marker (e.g., P16)
expression.

Patients who do not undergo hysterectomy are followed every 6 months for 2 years. All other
patients are followed at 4, 26, and 30 weeks.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5 years.