Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Number of circulating tumor cell detected after cervical cancer surgery.
研究概览
简要总结
Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.
The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.
详细描述
CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.
Despite recommendations for coelioscopic treatment of < 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.
Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.
This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Woman >18 years old
- •Cervical cancer confirmed by histology
- •Early stage eligible for immediate surgical treatment (or post-brachytherapy): stages IA1, 1A2, 1B1 and IB2 with or without emboli determined by MRI performed as part of the treatment
- •Histology : epidermoid carcinoma and adenocarcinoma
- •Valid Social Security
- •Wrote consent
排除标准
- •Advanced stage (Stage IB3 and more)
- •Concomitant cancer
- •Pregnant or breastfeeding woman
- •Vulnerable person (Article L1121-6 of the Public Health Code)
- •Participation to other study with an exclusion period still in progress
- •Participation to other study that may have an impact on the prognosis of cervical cancer
研究组 & 干预措施
Early stage cervical cancer
Patients with cervical cancer eligible for surgery, stage IA1 to IB2
干预措施: Blood samples (Other)
结局指标
主要结局
Number of circulating tumor cell detected after cervical cancer surgery.
时间窗: Within 48 hours after surgery.
Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)
次要结局
- Evaluation of disease-free survival(Two points at the 3rd and 5th years)