ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- This study will further evaluate the use of tumor markers (substances in body fluids that may be elevated as a consequence of certain diseases or conditions) in the diagnosis of breast and/or other cancers.
研究概览
简要总结
This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.
详细描述
Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Female or male, 18-100 years old
- •Patients who present for a routine check-up
- •Patients who present for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
- •May or may not have a mass present
- •Patients who present for the evaluation of a palpable lump or mass
- •Patients may be pre or post biopsy for a mass, as long as there is a portion of the mass remaining
排除标准
- •Patient < 18 y/o or > 100 y/o
- •Concurrent eye infection or trauma
- •Active conjunctivitis
- •Abnormal production of tears (too much or too little)
研究组 & 干预措施
1
干预措施: Tear collection (Other)
结局指标
主要结局
This study will further evaluate the use of tumor markers (substances in body fluids that may be elevated as a consequence of certain diseases or conditions) in the diagnosis of breast and/or other cancers.
时间窗: Collection of specimen and analysis with SELDI-MS
次要结局
未报告次要终点