Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 684
- 试验地点
- 2
- 主要终点
- Expression of the MN antigen in cytologic preparations that have been classified as AGUS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Expression of the MN antigen in cytologic preparations that have been classified as AGUS
时间窗: Baseline
Number of cervical specimens identified as having or not having glandular and/or squamous neoplasia
时间窗: Baseline
次要结局
- Specificity for HIV testing(Baseline)
- 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)
- Specificity of the expression of the MN antigen(Baseline)
- 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)
- Sensitivity for HIV testing(Baseline)
- Sensitivity of the expression of the MN antigen(Baseline)