The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 28
- 主要终点
- Evidence of Precachexia
研究概览
简要总结
The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue.
详细描述
Doctors, researchers, and patient advocates from numerous institutions throughout the state of Florida have formed a partnership known as the Florida Pancreas Collaborative. The goals of the Florida Pancreas Collaborative team are to find better ways to diagnose and treat pancreatic cancer and improve quality of life. Recent research suggests that pancreatic cancer affects people of various racial and ethnic groups differently, with some groups having more aggressive disease and a poorer prognosis than other groups.
In this research study, the investigators want to partner with individuals known or suspected to have pancreatic cancer to build a 'biobank' dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a valuable resource that involves collection, processing, and storage of blood, other bodily fluids, and tissue (obtained during biopsy or surgery) to improve the investigator's understanding of health and disease. When combined with information and medical images obtained through routine care, the investigators will be able to investigate biological processes that may underlie differences and poor outcomes and target them with more effective therapeutic strategies tailored to the individual.
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
- •18 years of age or older.
- •Patient presents for evaluation at a participating site with a strong clinical suspicion or diagnosis of a pancreatic cancer primary based on symptoms, imaging, biopsy, and/or blood-work and has not had treatment.
- •Patient self-reports as Non-Hispanic White, African American, or Hispanic.
- •Able to understand and voluntarily sign the informed consent.
- •Willing to complete study questionnaire(s) and donate medical images and biological specimens (including tissue and blood) obtained at the time of standard of care procedures (biopsy, surgery, and/or venipuncture) after signing the informed consent document.
排除标准
- •No suspicion or diagnosis of pancreatic cancer.
- •Has a diagnosis of pancreatic cancer but and has already undergone treatment (which may include surgery, chemotherapy, and/or radiation).
- •Self-reported race/ethnicity other than Non-Hispanic White, African American, or Hispanic.
- •Unable to provide informed consent.
- •Unwilling to complete study questionnaires(s) and/or donate biological specimens
结局指标
主要结局
Evidence of Precachexia
时间窗: Up to 12 months
Cases will be evaluated for precachexia using the following guidelines: Anorexia with \<5% weight loss over past 6 months along with metabolic changes that together indicate precachexia.
Evidence of Refractory Cachexia
时间窗: Up to 12 months
Cases will be evaluated for refractory cachexia using the following guidelines: Anorexia \>5% weight loss over 6 months along with specific metabolic changes that together indicate refractory cachexia.
Evidence of Cachexia
时间窗: Up to 12 months
Cases will be evaluated for cachexia using the following guidelines: Anorexia with \>5% weight loss over past 6 months, along with metabolic changes that together indicate cachexia.
Presence of Myopenia
时间窗: Up to 12 months
Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.
Presence of Visceral Adiposity
时间窗: Up to 12 months
Using CT scans at the axial L2-L3 level, the following radiologic measures of abdominal adiposity will be obtained: visceral fat area (VFA), subcutaneous fat area (SFA), total abdominal fat (TAF) area, and the VFA to SFA ratio (V/S). The VFA to SFA ratio (V/S) will be calculated with V/S \> 0.4 defined as viscerally obese.
次要结局
- Progression Free Survival(Up to 24 months)
- Overall Survival(Up to 24 months)