Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
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.
Other: laboratory biomarker analysis
Procedure: colposcopic biopsy
|Study Design:||Primary Purpose: Diagnostic|
|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|
- None specified [ Designated as safety issue: No ]
|Study Start Date:||September 1998|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003384
|Study Chair:||Shu-Yuan Liao||St. Joseph Hospital Regional Cancer Center - Orange|