Pilot Trial to Identify microRNAs in Cachexia in Patients With Pancreatic Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of African American pancreatic cancer patients with weight loss and cachexia.
研究概览
简要总结
The purpose of this study is to determine the proportion of pancreatic patients who experience weight loss and cachexia, and to identify any differences in the genes between patient groups.
详细描述
This research study will retrospectively examine 1395 patients from the University of Alabama and the University of Oklahoma Stephenson Cancer Center (OU-SCC) pancreatic cancer cohorts. The prospective arm, will enroll a total of 100 eligible volunteers at the OU-SCC. The demographic and medical data from the retrospective and prospective arms will be combined (1495 patients) to ascertain any racial disparities in pancreatic cancer patients with cachexia. Perspective volunteers at the OU-SCC will undergo routine tests to determine if their cancer is operable. Pancreatic tumors will be removed from the eligible patients, as part of their normal standard of care and will be examined for genes that may be related to unexplained muscle loss and compared to tumor tissue from other patients with pancreatic cancer. An optional hand strength exam, and standing on a scale that measures weight, muscle, and body fat will be available to OU-SCC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Male or female patient, who is ≥ 18 years old at the time of informed consent.
- •Patients with operable pancreatic tumors diagnosed in the last 12 months prior to consent with clinical discretion or pathology confirmed as adenocarcinoma.
- •Patient has stage I or higher disease who is considered a candidate for surgical resection of pancreatic cancer, with or without neoadjuvant chemotherapy.
- •Ability to provide written informed consent and HIPAA authorization.
排除标准
- •Patients with pancreatic adenocarcinoma who do not meet the criteria for surgical resection.
- •Patient has cancer diagnosis other than primary pancreatic adenocarcinoma.
结局指标
主要结局
Proportion of African American pancreatic cancer patients with weight loss and cachexia.
时间窗: 1 - 12 months
Evaluate weight loss and the markers of cachexia, albumin and psoas cross-sectional area, to see if African Americans with pancreatic cancer patients experience Grade I-IV cachexia at a higher frequency than other racial groups.
次要结局
- Differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery.(1 - 12 months)
- Differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups.(1 - 12 months)