Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic Closed 18 and over NCI GOG-171 GOG-0171, NCT00003384

Objectives

1. 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).
2. Measure the frequency and type of cervical pathology associated with the diagnosis of AGUS in these patients.
3. 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.
4. Determine the relationship between MN antigen expression and the presence of high-risk HPV in these patients.

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

None specified

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.

Liao SY, Rodgers WH, Bonfiglio T, et al.: Carbonic anhydrase IX (CAIX) and human papillomavirus (HPV) as potential diagnostic biomarkers of cervical dysplasia/neoplasia in women with a cytologic diagnosis of atypical glandular cells of undetermined significance (AGUS): a Gynecologic Oncology Group (GOG) study. [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-321, 2007.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Shu-Yuan Liao, Protocol chair		Ph: 714-771-8176

Registry Information
Official Title		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 Start Date		1998-09-28
Registered in ClinicalTrials.gov		NCT00003384
Date Submitted to PDQ		1998-06-25
Information Last Verified		2005-10-21
NCI Grant/Contract Number		CA27469

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