Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Long-term follow up to support clinical and preclinical research
研究概览
简要总结
Background:
Certain stomach cancers are rare, but they have high mortality rates. Researchers want to learn more about gastric (stomach) tumors. In this study, they want to collect data from people who have stomach cancer or are at risk to get it. This data will be used to see if the people can be in other studies.
Objective:
To study tissue from stomach tumors and find people eligible for more studies on gastric cancer.
Eligibility:
Age greater than or equal to 2 years old who have or may have stomach cancer, lesions that may be related to stomach cancer, or an inherited disorder that leads to stomach cancer.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Heart tests
Scans or ultrasound.
For the scans, participants lie in a machine that takes pictures. For some scans, they will swallow or be injected with a small amount of radioactive material. Special cameras will show the material in the body.
Tumor sample taken with a needle or surgery
Some participants will have an endoscopy. A long, flexible tube with a camera will be inserted through the mouth into the stomach. The tube will collect tissue from the stomach.
Some participants may have follow-up visits. Some may be invited to join other studies. Others will be contacted by phone to see how they are doing.
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详细描述
Background:
- Greater than 90% of gastric tumors are of epithelial origin and are classified as adenocarcinomas; the remainders include GIST, carcinoid and lymphoma.
- Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000).
- Mortality rates are high with an estimated 5-year overall survival of 25% - 30%.
- Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome.
- Molecular sub-classification of gastric adenocarcinomas has been reported, however translation of these findings into clinical management of patients has yet to occur.
Objectives:
- To permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions.
- Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR.
- To allow long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy.
Eligibility:
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Long-term follow up to support clinical and preclinical research
时间窗: follow up
long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
Determination of eligibility
时间窗: at initial visit
determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR
Clinical and laboratory evaluation and molecular profiling of tumor tissue
时间窗: at initial visit and as clinically indicated
Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
次要结局
未报告次要终点