Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 13
- 主要终点
- Creation of participant registry
研究概览
简要总结
The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.
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
- 是
入选标准
- •Age ≥ 18 years old
- •Able to read and understand English and Spanish
- •Meet criteria for one of three potentially eligible study populations:
- •Individuals with gastric atrophy, gastric intestinal metaplasia, or dysplasia: Had a previous diagnosis of or have been diagnosed by the investigation team with gastric atrophy, gastric intestinal metaplasia, or dysplasia of the gastric mucosa on pathology review from an endoscopic biopsy. Individuals who have a prior history of early gastric cancer may be included, if they were treated endoscopically and have no evidence of disease. Individuals who have a prior history of a cancer other than upper gastrointestinal cancer may also be included, if they have no evidence of disease for at least 1 year prior to study enrollment and are not undergoing active treatment for any malignancy at any time throughout the study period
- •Healthy controls (average risk): Individuals with no history of cancer or gastric precursor lesions undergoing a clinically indicated endoscopy at MSK for workup or dyspepsia or reflux
- •Gastric cancer cases: Individuals with a known diagnosis of early gastric adenocarcinoma undergoing surgical resection at MSK
排除标准
- •Age < 18 years old
- •Women who are pregnant (may be enrolled after delivery)
- •Individuals with a prior history of upper gastrointestinal surgery or a prior cancer who are undergoing active treatment for malignancy or have been diagnosed within 1 year prior to the study enrollment or with pancreatic cancer. (This does not include incidentally diagnosed primary gastric adenocarcinoma identified during study follow up. Individuals diagnosed with gastric carcinoid limited to the stomach will also be included, given their ongoing parallel risk for gastric adenocarcinoma.)
- •Have severe comorbidities with expected survival time <2 years or which would prevent them from undergoing routine elective EGD (at the discretion of the patient's provider and the study team)
- •Individuals having Hereditary Diffuse Gastric Cancer Syndrome, mutations including CDH1 and CTNNA1, or more than one genetic mutation
- •Exclude high risk esophageal and duodenal lesions including:
- •Duodenal Adenoma
- •Dysplasia or cancer at the esophagus or gastroesophageal junction
- •Patients with an increased risk for biopsies during EGD, such as those with clotting disorders.
研究组 & 干预措施
Participants with atrophic gastritis, intestinal metaplasia, and dysplasia
Participants with presence of atrophic gastritis, intestinal metaplasia, and dysplasia and risk of the progression of these lesions
干预措施: Questionnaire (Behavioral)
Control Group
Healthy controls
干预措施: Questionnaire (Behavioral)
Participants with gastric cancer
Participants with gastric cancer
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Creation of participant registry
时间窗: Up to 10 years
The primary objective of this study is to create a registry of individuals with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.
次要结局
未报告次要终点