Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery
研究概览
简要总结
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery.
详细描述
OBJECTIVES:
- Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and volunteers undergoing colonoscopy, endoscopy, or surgery.
- Develop new screening strategies based on substances found in tissue and biofluid samples.
OUTLINE: This is a multicenter study.
Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database.
Patients are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •DISEASE CHARACTERISTICS:
- •Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND
- •Meets 1 of the following criteria:
- •Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease
- •History of previously treated GI cancer, polyps, or inflammatory bowel disease
- •PATIENT CHARACTERISTICS:
- •Capable of giving informed consent
- •Not mentally or medically impaired
- •No bleeding disorder
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery
时间窗: Through study completion, approximately 30 years
Genomic and proteomic biomarkers
Development of new screening strategies based on substances found in tissue and biofluid samples
时间窗: Through study completion, approximately 30 years
Genomic and proteomic biomarker discovery
次要结局
未报告次要终点
研究者
Kristen K Ciombor
Associate Professor of Medicine
Vanderbilt University Medical Center