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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003384
First received: November 1, 1999
Last updated: May 27, 2015
Last verified: May 2015
  Purpose
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.

Condition Intervention
Precancerous Condition
Stage 0 Cervical Cancer
Other: Cervical Papanicolaou Test
Procedure: Conization
Other: Laboratory Biomarker Analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Expression of the MN antigen in cytologic preparations that have been classified as AGUS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sensitivity for HIV testing [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Sensitivity of the expression of the MN antigen [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Specificity for HIV testing [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Specificity of the expression of the MN antigen [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 684
Study Start Date: September 1998
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Cervical Papanicolaou Test
Undergo Pap smear
Other Name: Cervical Pap Test
Procedure: Conization
Undergo cone biopsy
Other Names:
  • cone biopsy
  • Cone Biopsy of Cervix
  • Conization of Cervix
  • Conization of Uterine Cervix
Other: Laboratory Biomarker Analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003384

Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shu-Yuan Liao Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003384     History of Changes
Other Study ID Numbers: GOG-171  NCI-2012-02269  CDR0000066380  GOG-171  GOG-0171 
Study First Received: November 1, 1999
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 28, 2016