Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
This diagnostic trial is studying the presence of a specific protein as a potential biomarker
 of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to
 determine whether a patient has cervical dysplasia and/or cancer.
OBJECTIVES:

 I. 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).

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

 III. 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.

 IV. 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.
Inclusion Criteria:

 -  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

 -  HIV negative

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

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

 -  No prior radiotherapy to the vagina or cervix

 -  No concurrent radiotherapy to the vagina or cervix

 -  No prior hysterectomy