RATIONALE: The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.

PURPOSE: This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer.

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.

• Cervical Cancer
• Precancerous/Nonmalignant Condition

• Other: laboratory biomarker analysis
• Procedure: biopsy
• Procedure: colposcopic biopsy

DISEASE CHARACTERISTICS:

• Cytologically confirmed atypical glandular cells of undetermined significance (AGUS)
• Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS
• No history of endometrial hyperplasia
• No history of cancer of the endometrium, vagina, or cervix

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• HIV negative
• No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy for vaginal and/or cervical cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the vagina or cervix
• No concurrent radiotherapy to the vagina or cervix

Surgery

• See Disease Characteristics
• No prior hysterectomy