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

May 27, 2015 updated by: Gynecologic Oncology Group

Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

684

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Gynecologic Oncology Group of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diagnostic

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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Cervical Papanicolaou Test
Undergo Pap smear
Other Names:
  • Cervical Pap Test
Procedure: Conization
Undergo cone biopsy
Other Names:
  • cone biopsy
  • Cone Biopsy of Cervix
  • Conization of Cervix
  • Conization of Uterine Cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression of the MN antigen in cytologic preparations that have been classified as AGUS
Time Frame: Baseline
Baseline
Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Ability of the MN antigen marker to be able to correctly predict patients who do not have glandular and/or squamous neoplasia
Time Frame: Up to 2 years
Up to 2 years
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
Time Frame: At 1 year
At 1 year
Sensitivity for HIV testing
Time Frame: Baseline
Baseline
Sensitivity of the expression of the MN antigen
Time Frame: Baseline
Baseline
Specificity for HIV testing
Time Frame: Baseline
Baseline
Specificity of the expression of the MN antigen
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-171 (OTHER: Gynecologic Oncology Group)
  • NCI-2012-02269 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CDR0000066380
  • GOG-0171 (OTHER: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe