Prognostic and Predictive Impact of Circulating Tumor DNA in Advanced and Localized Gastric Cancer Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. The management of treatment for gastric cancer needs the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.
Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy regimen.
详细描述
Introduction The cell lysis phenomena tumor releases DNA that can be detected in the blood and in other biological fluids such as lymph, urine or stool. An increase in plasma levels of tumor DNA is described in patients with cancer, and recently, monitoring of circulating tumor DNA that has been proposed as a relevant potential marker to assess the prognosis and the early response to treatment of colon or breast cancers (Dawson et al, 2013; Spindler et al, 2013; Tie et al, 2015). However, there is no data on the prognostic and predictive impact of circulating tumor DNA in context of gastric cancer treatment.
The aim of this study is to evaluate the correlation between the level of circulating tumor DNA and prognosis or response to treatment of localized and advanced gastric cancer.
Patients and Methods:
Three university hospitals of "Assistance Publique Hôpitaux de Paris" (AP-HP) will participate in this prospective study: European Georges Pompidou hospital, Pitié-Salpêtrière hospital and Cochin hospital. Inclusion criteria were all patients aged over 18 years with localized or advanced adenocarcinoma of gastric or gastro-oesophageal junction, histologically proven. The patients will be enrolled over a period of 2 years after receiving and signed a specific consent information form.
This is a non-interventional study who does not change the management of patients. There will be no additional invasive procedures to those already scheduled for routine care. Blood samples will be made at the time of chemotherapy sessions from the Huber needle previously implanted in the port-a-cath for the administration of chemotherapy agents.
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
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged over 18 years
- •histologically proven adenocarcinoma of gastric or gastro-oesophageal junction
- •And receiving treatment:
- •For localized tumor stage: surgical resection associated with perioperative chemotherapy, adjuvant chemotherapy or adjuvant chemoradiotherapy
- •For advanced tumor stage: first-line palliative chemotherapy
排除标准
- •All patients unable to undergo medical monitoring study for geographical, social or psychic reasons ;
- •Patients under guardianship or unable to read, understand and sign the information sheet and consent form;
- •Non-affiliated to the French social security institution
结局指标
主要结局
Progression free survival (PFS)
时间窗: Time from the start of treatment until progression disease (advanced tumor cohort) assessed up to 9 months, or recurrence (localized tumor) assessed up to 24 months
PFS will be evaluated according to the circulating tumor DNA
次要结局
- Tumor response rate(Tumor response rate according to the RECIST 1.1 criteria. This outcome measure will be assessed through study completion, an average of 6 months)
- Overall survival (OS)(Time from the start of treatment until death assessed up to 24 months (advanced tumor cohort))
研究者
Dr. Aziz Zaanan
MD, PhD
Association des Gastroentérologues Oncologues