NCT05338060已完成不适用
A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.
研究概览
简要总结
The purpose of this research is to collect surgical drain fluid and blood from patients who have undergone surgery for gastric or esophageal cancer, and to analyze the fluid and blood using a variety of laboratory techniques for molecular markers capable of predicting response to immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 undergoing esophagectomy or gastrectomy for gastroesophageal cancer.
- •Adult males and females at least 18 years of age
- •Ability to complete testing in the protocol and attend study visits
- •Able and willing to consent to protocol
- •Adequate organ function Absolute Neutrophil Count (ANC) ≥1.5 x 103/μL Platelets ≥100 x 103/μL Hemoglobin >9.0 g/dL Total Bilirubin (</= 2.0 mg/dl at time of Y90 radioembolization) AST/ALT ≤5 x upper limit of normal Albumin >3 g/dL Creatinine ≤1.5 mg/dL
排除标准
- •Female patients who are pregnant or breast-feeding
- •Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
- •Life-threatening intercurrent illness
- •Anticipated poor compliance
- •Prisoners or subjects who are involuntarily incarcerated
- •Persons with decisional incapacity/cognitive impairment
- •Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study
- •Subject is enrolled in a separate interventional clinical trial
结局指标
主要结局
Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.
时间窗: 6 months
to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection.
次要结局
- Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.(24 months)
研究者
研究点 (1)
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