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

Precancerous Condition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003384
• Other study ID #: GOG-171
• Secondary ID: NCI-2012-02269CD
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: May 27, 2015
• Start date: September 1998

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Stage 0 Cervical Cancer
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Other:
• Cervical Papanicolaou Test
Undergo Pap smear

Procedure:
• Conization
Undergo cone biopsy

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group of Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of the MN antigen in cytologic preparations that have been classified as AGUS		Baseline	No
Primary	Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia		Baseline	No
Secondary	Ability of the MN antigen marker to be able to correctly predict patients who do not have glandular and/or squamous neoplasia		Up to 2 years	No
Secondary	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		At 1 year	No
Secondary	Sensitivity for HIV testing		Baseline	No
Secondary	Sensitivity of the expression of the MN antigen		Baseline	No
Secondary	Specificity for HIV testing		Baseline	No
Secondary	Specificity of the expression of the MN antigen		Baseline	No