Clinical trial NCT00003384: Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Condition
Stage 0 Cervical Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 684
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Expression of the MN antigen in cytologic preparations that have been classified as AGUS
timeFrame: Baseline
measure: Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia
timeFrame: Baseline
Secondary outcomes:
measure: Ability of the MN antigen marker to be able to correctly predict patients who do not have glandular and/or squamous neoplasia
timeFrame: Up to 2 years
measure: Feasibility, based on the number of years required to complete the study, as determined by both the actual disease prevalence rate as well as the actual patient accrual rate
timeFrame: At 1 year
measure: Sensitivity for HIV testing
timeFrame: Baseline
measure: Sensitivity of the expression of the MN antigen
timeFrame: Baseline
measure: Specificity for HIV testing
timeFrame: Baseline
measure: Specificity of the expression of the MN antigen
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Gynecologic Oncology Group of Arizona
state: Arizona
Study officials:
affiliation: Gynecologic Oncology Group
name: Shu-Yuan Liao
role: PRINCIPAL_INVESTIGATOR
References: