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

NCT ID: NCT00003384

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 684 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

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.

Conditions

Precancerous Condition; Stage 0 Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cervical Papanicolaou Test

Intervention Type: OTHER

Undergo Pap smear

Conization

Intervention Type: PROCEDURE

Undergo cone biopsy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Cervical Papanicolaou Test

Undergo Pap smear

Intervention Type: OTHER

Conization

Undergo cone biopsy

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Cervical Pap Test; cone biopsy; Cone Biopsy of Cervix; Conization of Cervix; Conization of Uterine Cervix

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Yuan Liao

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

NCI-2012-02269

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000066380

Identifier Type: -

Identifier Source: secondary_id

GOG-171

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0171

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-171

Identifier Type: -

Identifier Source: org_study_id