Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peritoneal Regression Grading Score (PRGS)
研究概览
简要总结
PIPADN is a pilot monocentric, study with a total duration of 42 months. The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis.
The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey.
Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart. Two blood samples will be taken during the first 3 PIPAC sessions, one the day before each procedure and a second one 24 hours afterwards.
The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation (about 3 weeks after PIPAC sessions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •WHO 0 to 2
- •Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery
- •A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential.
- •Patient with an indication for PIPAC for any reason (whether as part of a clinical research protocol or not). Patients with prior treatment with PIPAC are eligible.
- •Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis).
- •For patients of childbearing age need for an effective method of contraception
- •Informing patients and obtaining informed consent, dated and signed.
- •Patient affiliated with a social security scheme
排除标准
- •Age < 18 years old
- •Patient who may benefit from cytoreduction surgery
- •Patient with a contraindication to PIPAC
- •Extra peritoneal disease with the exception of oligometastatic disease
- •Persons deprived of liberty or under guardianship (including curatorship)
- •Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons.
- •For patients of childbearing age without an effective method of contraception
- •Woman who is pregnant, likely to be pregnant, or breastfeeding
研究组 & 干预措施
Blood sample (20ml) and Quality of Life Survey
干预措施: Blood sample (20 ml) and EORTC QLQC30 survey (Other)
结局指标
主要结局
Peritoneal Regression Grading Score (PRGS)
时间窗: an average of 12 weeks
Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells
ctDNA
时间窗: change from inclusion at 12 weeks
ctDNA concentration change (ng/mL)
Peritoneal Regression Grading Score (PRGS)
时间窗: at inclusion
Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells
Peritoneal Regression Grading Score (PRGS)
时间窗: an average of 6 weeks
Results of each PIPAC will be evaluated using PRGS. PRGS : (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells
次要结局
- Peritoneal cancer index mesure(an average of 12 weeks)
- PIPAC discontinuation(an average of 12 weeks)
- Quality of life mesure(an average of 15 weeks)
- PIPAC discontinuation(an average of 6 week)
- Peritoneal cancer index mesure(at inclusion)
- Peritoneal cancer index mesure(an average of 6 week)
- Quality of life mesure(At inclusion)
- Quality of life mesure(an average of 3 weeks)
- Quality of life mesure(an average of 9 weeks)