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

This study is currently recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer

Study Type: Interventional
Study Design: Diagnostic

Official Title: Study of MN Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Neoplasia in Patients With Atypical Glandular Cells of Undetermined Significance

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • See Disease Characteristics
  • No prior hysterectomy

Location and Contact Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
William H. Rodgers, MD, PhD  205-934-5077 

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Alberto Manetta, MD  714-456-8200 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
Jonathan S. Berek, MD  310-206-5161 

      St. Joseph Hospital Regional Cancer Center - Orange, Orange,  California,  92868-3849,  United States; Recruiting
Shu-Yuan Liao  714-771-8176 

      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Nick M. Spirtos, MD  408-866-3843    nspirtos@wccenter.com 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
G. Scott Rose, MD  202-782-8515    scott.rose@na.amedd.army.mil 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
L. Stewart Massad, MD  217-545-8882 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michael W. Method, MD, MPH  574-237-8010    mmethod@mhopc.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Joel I. Sorosky, MD  319-356-2015    joel-sorosky@uiowa.edu 

Massachusetts
      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01605-2982,  United States; Recruiting
Susan L. Zweizig, MD  508-334-1160    zweizig@ummhc.org 

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237    beekmanl@trinity-health.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
John Bomalaski, MD  228-377-6396    john.bomalaski@keesler.af.mil 

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Sara Crowder, MD  573-882-1057    crowders@health.missouri.edu 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
David P. Warshal, MD  856-342-2185    warshal-david@cooperhealth.edu 

New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
Michael L. Pearl, MD  631-444-2774 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Carol L. Brown, MD  212-639-7659 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Andrew Menzin, MD  516-562-4438    amenzin@nshs.edu 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Shashikant B. Lele, MD  716-845-5776    shashi.lele@roswellpark.org 

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
Brigitte E. Miller, MD  336-716-6673    bemiller@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Daniel L. Clarke-Pearson, MD  919-684-3765 

      Gynecologic Oncology Network, Greenville,  North Carolina,  27858,  United States; Recruiting
Howard David Homesley, MD  252-756-5388    hdh7173@aol.com 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Wesley C. Fowler, MD  919-966-1196    wfowler@med.unc.edu 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Jeffrey McCabe Fowler, MD  614-293-8737 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
Nader Husseinzadeh, MD  513-558-8450    nallerhusseinzadeh@uc.edu 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Steven E. Waggoner, MD  216-844-5011 

Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Robert S. Mannel, MD  405-271-8787    robert-mannel@ouhsc.edu 

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
Parviz Hanjani, MD  215-885-0220    phanjani@amh.org 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Nava Siegelmann-Danieli, MD  570-271-6834    nsdanieli@geisinger.edu 

      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Joseph L. Kelley, MD  412-641-5418    jkelley@mail.magee.edu 

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
Kenneth F. Cofer, MD  865-673-9250 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Marta Ann Crispens, MD  615-322-2114    marta.crispens@vanderbilt.edu 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Edward V. Hannigan, MD  409-772-2368    ehanniga@utmb.edu 

Vermont
      Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington,  Vermont,  05401,  United States; Recruiting
Cheung Wong, MD  802-847-5110    cheung.wong@vtmednet.org 

Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting
Roger B. Lee, MD  253-403-1029    rogerblee@aol.com 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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