NCT02784366Unknown不适用
GI Complications in Cancer Immunotherapy Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biospecimen collection
研究概览
简要总结
The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
详细描述
Primary objective
- To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy
Secondary objective
- Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
- Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
- Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Confirmed diagnosis of cancer
- •Currently undergoing or have undergone immunotherapy
排除标准
- •History of a total colectomy
- •History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
- •History of colitis on chemotherapy
结局指标
主要结局
Biospecimen collection
时间窗: 12 weeks
To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy.
GI disease activity
时间窗: 12 weeks
To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
次要结局
未报告次要终点
研究者
Michael Dougan
Attending physician
Massachusetts General Hospital
研究点 (1)
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