Evaluation Of The Diagnostic And Prognostic Value Of Immunohistochemical Markers In Precancerous Lesions Of The Cervix
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Expression of BAG3
研究概览
简要总结
The study aims to evaluate the expression of certain proteins and their diagnostic and prognostic value in precancerous lesions of the cervix.
详细描述
Cervical cancer is the second most common malignancy in women and the most common gynaecological cancer worldwide. Numerous risk factors are associated with the development of cervical cancer; in particular, human papilloma virus (HPV) infection plays a decisive role in the development of the neoplasm. Almost all cervical cancers are caused by persistent human papilloma virus (HPV) infections.
In particular, squamous cell carcinoma accounts for about 70% of cervical cancers; its precursor is called 'cervical intraepithelial neoplasia' (CIN) or 'squamous intraepithelial lesion' (SIL) and is classified according to the degree of dysplasia. The 'CIN' classification system defines three categories: CIN1 (dysplasia limited to the lower third of the epithelium), CIN2 (dysplasia extending into the middle third of the epithelium) and CIN3 (dysplasia extending into the upper third of the epithelium). More recently, the 'CIN' system has been replaced by the 'SIL' system, which appears more reproducible and biologically relevant. The 'SIL' system reduces the categories from three to two: low grade - SIL (L - SIL, overlapping CIN1) and high grade - SIL (H - SIL, grouping CIN2 and CIN3 together).
Several diagnostic markers have been proposed, such as athanogene 3 associated with Bcl - 2 (BAG3) and others with prognostic value such as topoisomerase 2A (TOP2), minichromosome maintenance protein 2 (MCM 2), Ki-67, P16INK4, P-53 associated with cervical cancer. However, there is no strong evidence for the association of these markers with precancerous lesions.
Our study therefore aims to investigate the diagnostic and prognostic value of Bcl-associated athanogene 3 - 2 (BAG3) in patients diagnosed with CIN/SIL undergoing colposcopic cervical biopsies or conization.
This clinical trial is therefore a tissue-based, diagnostic and prognostic accuracy, retrospective cohort, single-center, non-profit, pilot study and foresees that histological sections obtained at the time of initial diagnosis will be re-evaluated in blinded fashion by two pathologists regarding histological diagnosis, histotype, histological grading, lymphocytic infiltrate. They will then be subjected to immunohistochemistry according to the specific protocol for BAG3.
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
- •Patients with a diagnosis of CIN/SIL undergoing cervical biopsy/concussion whose tissue sample is archived at the Operative Unit of Pathological Anatomy and Histology
- •Obtaining written informed consent for the use of biological samples
- •Patients aged 18 years and over
排除标准
- 未提供
研究组 & 干预措施
Patients diagnosed with precancerous lesions of the cervix CIN/SIL
Patients diagnosed with precancerous lesions of the cervix CIN/SIL undergoing diagnostic biopsy/uterine conization since January 2000
干预措施: Tissue, diagnostic and prognostic accuracy (Diagnostic Test)
结局指标
主要结局
Expression of BAG3
时间窗: enrollment through study completion, an average of 1 year
Expression of BAG3 in patients diagnosed with precancerous lesions of the cervix
次要结局
- Evolution of bag3 expression over time(After enrollment, through study completion, an average of 1 year)
- Correlation between BAG3 expression and the degree of dysplasia of cervical lesions(After enrollment, through study completion, an average of 1 year)