CERvical Cance The InFlammatory Index as a Predictor of risK Stratification:an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Grading
研究概览
简要总结
Although significant advances in screening and treatment , cervical cancer is the fifth most common female cancer in Europe. Major prognostic factors for oncological outcome are used to categorise patients at high, intermediate and low risk groups and to define the type of radical hysterectomy according "Querleu-Morrow classification". The goal of this prospective observational study is to evaluate the association between several inflammatory markers and risk groups according European guidelines in women with cervical cancer Human Papillomavirus (HPV)-associated, in order to optimize the treatment.
详细描述
European guidelines have proposed a risk stratification of patients basing on oncological risk. The type of radical hysterectomy (extent of parametrial resection and type according Querleu-Morrow classification) should be based upon the presence of prognostic risk factors.Major prognostic factors for oncological outcome as tumour size, maximum stromal invasion, Lymphovascular space invasion (LVSI) are used to categorise patients at high, intermediate and low risk for treatment failure. The investigators want to identify additional parameters to better define risk profiles. Systemic inflammation indices such as neutrophil to lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and lymphocyte to monocyte ratio (LMR) have shown prognostic value in solid tumors and several inflammatory conditions. Therefore, the primary endpoint of the present study is to assess the role of systemic inflammatory indices and risk groups stratification in patients with early cervical cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18-year-old patients.
- •Patients histologically diagnosed with cervical cancer (squamous cell carcinoma or adenocarcinoma HPV- associated)
- •Patients with (2018 FIGO) stage ≤ IB2 ("Early Cervical Cancer")
- •Patients undergoing full-body CT-scan 30 days before enrollment.
排除标准
- •Patients unfit to plead
- •Patients with chronic inflammatory diseases (IBDs; rheumatic conditions)
- •Synchronous tumors or cancer diagnosis in the previous 3 years
- •Patients undergoing steroid therapy in the last 30 days prior to recruitment
研究组 & 干预措施
Cervical cancer patients
The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer.
干预措施: Venous blood sample (Diagnostic Test)
Cervical cancer patients
The population is represented by women being admitted to the Gynecology Ward who are affected by cervical cancer.
干预措施: biopsy (Procedure)
结局指标
主要结局
Grading
时间窗: 30 days after surgery
Anatomic pathology report of cell anaplasia in the sampled tumor
Staging
时间窗: 30 days after surgery
Anatomic pathology report of extent to which the cancer has spread
Lymphovascular space invasion
时间窗: 30 days after surgery
Prognostic factor in cervical cancer
Histotype
时间窗: 30 days after surgery
Anatomic pathology report of tissue types of cancer
Tumor size
时间窗: 30 days after surgery
centimeters
Platelet-lymphocyte ratio(PLR)
时间窗: 1 day previous surgery
an absolute value obtained from the ratio of platelets to lymphocytes
Lymphocyte-monocyte Ratio (LMR)
时间窗: 1 day previous surgery
an absolute value obtained from the ratio of lymphocytes to monocytes
Neutrophil-Lymphocyte Ratio (NLR)
时间窗: 1 day previous surgery
an absolute value obtained from the ratio of neutrophils to lymphocytes
次要结局
未报告次要终点
研究者
Carlo Ronsini
Principal Investigator
University of Campania Luigi Vanvitelli