跳至主要内容
临床试验/NCT02803515
NCT02803515终止不适用

HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
主要终点
Changes in serum levels of HSP90 and 70 on peripheral venous samples.

研究概览

简要总结

Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
Female
接受健康志愿者

入选标准

  • Females over 18 years.
  • Indication of Hyperthermic Intra Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis from ovarian origin
  • Obtaining written informed consent and signed for participation in the study and conservation of samples taken.
  • Affiliation to a social security scheme.
  • Non-inclusion criteria
  • Major patients protected by law or deprived of liberty.
  • Patients pregnant women in labor or breastfeeding.
  • Refusal of participation
  • Another cause of peritoneal carcinomatosis

排除标准

  • consent withdrawn

研究组 & 干预措施

Patient with HIPEC

Experimental

干预措施: peripheral venous blood samples (Biological)

Patient without HIPEC

Sham Comparator

干预措施: peripheral venous blood samples (Biological)

结局指标

主要结局

Changes in serum levels of HSP90 and 70 on peripheral venous samples.

时间窗: basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)

Changes in serum levels of HSP90 and 70 postoperatively HIPEC (Day 1, day 3 and day 5 postoperative) compared to basal levels measured preoperatively on peripheral venous samples. Patients who had HIPEC will be compared with patients overturned on early intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验