Kinetics of Perioperative Circulating DNA in Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in concentration of total mutant circulating DNA
研究概览
简要总结
The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is aged between 18-75
- •Patient must weigh >40kg
- •The patient will receive adjusted carcinological surgery
- •Indication of curative surgery
- •The patient has already undergone tumoral biopsy prior to surgery
- •The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)
排除标准
- •The subject is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is pregnant, parturient or breast feeding
- •Chronic alcoholism
- •The patient has received radiotherapy or chemotherapy periopratively
- •Cancer other than colon, breast or prostate
- •The patient has currently or in the past, had a cancerous lesion
- •Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)
- •Emergency cancer surgery
结局指标
主要结局
Change in concentration of total mutant circulating DNA
时间窗: Nine timepoints between Day-1 to Day 3
ng/mL in plasma
Change in proportion of mutant circulating DNA
时间窗: Nine timepoints between Day-1 to Day 3
ng/mL in plasma
Change in integrity index of circulating DNA for ACTB gene
时间窗: Nine timepoints between Day-1 to Day 3
concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments
Change in integrity index of circulating DNA for KRAS gene
时间窗: Nine timepoints between Day-1 to Day 3
concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments
次要结局
- Change in plasma concentration of short (~ 145bp) fragments of KRAS gene(Nine timepoints between Day-1 to Day 3)
- Change in plasma concentration of BRAF DNA fragments with V600E mutation(Nine timepoints between Day-1 to Day 3)
- Change in plasma concentration of long (~ 300bp) fragments of KRAS gene(Nine timepoints between Day-1 to Day 3)
- Change in plasma concentration of mutant KRAS DNA fragments(Nine timepoints between Day-1 to Day 3)
- Change in plasma concentration of long (~ 290bp) fragments of ACTB gene(Nine timepoints between Day-1 to Day 3)