NCT06889844招募中不适用
Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
ADVANCED MARKER DISCOVERY S.L.5 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- False Positive Rate
研究概览
简要总结
The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is
Does the blood test have a low false positive rate in the main study population?
Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.
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
- •Patients older than 18 years of age at the time of blood sample collection.
- •Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
- •Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.
排除标准
- •Patients who have received previous chemotherapy or radiotherapy.
- •In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
- •Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
- •Patients without appropriate staging or diagnosis.
- •Patients with hemolyzed plasma.
结局指标
主要结局
False Positive Rate
时间窗: 36 month
To estimate the false positive rate of the blood-based test in the main population of the study
次要结局
未报告次要终点
研究者
研究点 (5)
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