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.

Condition	Treatment or Intervention
stage 0 cervical cancer Precancerous Condition	Procedure: biological markers  Procedure: biopsies  Procedure: colposcopic biopsy  Procedure: diagnostic test

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
      St. Joseph Hospital Regional Cancer Center - Orange, Orange,  California,  92868-3849,  United States; Recruiting
      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Massachusetts
      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01605-2982,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Gynecologic Oncology Network, Greenville,  North Carolina,  27858,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Vermont
      Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington,  Vermont,  05401,  United States; Recruiting
Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting

Study chairs or principal investigators

Shu-Yuan Liao,  Study Chair,  St. Joseph Hospital Regional Cancer Center - Orange   

Study ID Numbers:  CDR0000066380; GOG-171; NCT00003384
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003384
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08