Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Pancreatic cancer has a 5-year overall survival rate around 5%. It is the 6th most common cancer in France (11 600 new annual cases in 2012) and the 4th leading cause of cancer deaths in France and Europe.
Many translational research has tried to identify biomarkers in pancreatic cancer. Only the expression of hENT1 evaluated on the tumor tissue with the mouse antibody seems really relevant by providing a predictive value of the effectiveness of gemcitabine adjuvant. In a metastatic situation, there is no predictive marker of the effectiveness of chemotherapy treatments.
GemciTest(TM), studied in this study, is developed by the company Acobiom. Test based on the qRT-PCR technology that allows the establishment of a molecular signature of 10 genes that showed its interest as a biomarker in 60 patients with metastatic pancreatic adenocarcinoma treated with gemcitabine. Retrospective analysis differentiated 2 patient populations:
- 22 patients with a "favorable" expression gene with a median survival of 14.9 months
- 35 patients with an "adverse" expression gene with a median survival of 5.1 months
Primary objective: To evaluate in patients with pancreatic cancer, treated with Gemcitabine alone or combined (nab-paclitaxel) or with Folfirinox, the prognostic value of the GemciTest(TM) test on overall survival and response to treatment.
To realize this study, only one 2.5 mL blood sample is taken before starting chemotherapy. The standard practice data is then saved.
100 patients will be included.
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
- •Cytologically or histologically confirmed pancreatic cancer
- •Patient seeking first-line chemotherapy for pancreatic cancer
- •Age> 18 years
- •Presence of at least 1 measurable tumor lesion according to RECIST 1.1 criteria
- •Performance index ≤ 2
- •Patient able and willing to comply with the study procedures according to the protocol
- •Patient able to understand, sign and date informed consent
- •Affiliation to a social security scheme.
排除标准
- •Contraindication to chemotherapy
- •Anti-tumor therapy, experimental or not, recent in the last 4 weeks before the inclusion of the patient
- •Active infection requiring antibiotics within 14 days before inclusion
- •Patients unable to understand, read and / or sign informed consent
- •Persons benefiting from a protection system for adults (including tutorship and guardianship)
- •Pregnant or lactating women
结局指标
主要结局
Overall survival
时间窗: average of 1 year
Overall survival is defined as survival between Day 1 of the first line of chemotherapy and death
次要结局
未报告次要终点