Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)
研究概览
简要总结
This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a GI tumor
- •Must have planned standard of care surgical procedure
- •Age ≥ 18 years.
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •- Pattens who are unable to comply with the study protocol
研究组 & 干预措施
Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis
Subjects with gastrointestinal (GI) primary tumor with or without peritoneal carcinomatosis who are undergoing planned standard of care (SOC) surgical procedures. Biospecimens such as blood, peritoneal wash fluid and tumor samples will be obtained.
干预措施: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples) (Other)
结局指标
主要结局
Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)
时间窗: Up to 4 years
Successful establishment of multicellular pdPC VMT models from metastatic and/or primary tumor tissue with increasing tumor volume over a 14 day period.
Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)
时间窗: Up to 4 years
Establishment and evaluation of angioarchitecture of peritoneal lesions through OCTA imaging obtained during surgery.
次要结局
- Overall Survival (OS)(Up to 4 years)
- Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)(Up to 4 years)
- Progression-Free Survival (PFS) at 6 months(6 months)
研究者
Maheswari Senthil, MD
Professor of Surgery, Division Chief - Surgical Oncology
University of California, Irvine