Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study ("EXO-PPP Study")
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- • Characterization of the molecular profile in tumor derived exosomes from advanced gastric cancer patients undergoing first-line chemotherapy
研究概览
简要总结
Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis.
In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Subjects eligible for enrollment must meet all of the following criteria:
- •Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
- •Men or women aged >= 18 years.
- •Eastern Cooperative Oncology Group Performance Status (ECOG) <=
- •Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or esophagus.
- •Metastatic disease or locally advanced disease not amenable to curative surgery.
- •Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
- •Life expectancy of at least 12 weeks from the time of enrollment.
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- •No prior chemotherapy for advanced disease.
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Gastric carcinoid, sarcomas, or squamous cell cancer.
- •Pregnant or lactating females.
- •Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
- •Active Hepatitis B or C or history of an HIV infection.
- •Active uncontrolled infection.
结局指标
主要结局
• Characterization of the molecular profile in tumor derived exosomes from advanced gastric cancer patients undergoing first-line chemotherapy
时间窗: Up to 2 years from start of study
• Correlation of plasma level and kinetics of gastric cancer derived exosomes (at baseline and monthly during therapy until tumor progression or death) and time-to-event end-points: Overall survival, Progression-free survival and Overall response rate.
时间窗: Up to 3 years from start of the study
次要结局
未报告次要终点
研究者
Roberto A. Pazo-Cid
MD
Hospital Miguel Servet