Performance of Multi-Cancer Detection Test in Asymptomatic Patients With Neoplastic Lesions
Performance Validation of a Blood-Based Multi-Cancer Early Detection Model in Asymptomatic Patients With Cancer and Precancerous Lesions: A Multicenter Case-Only Study
This multicenter, observational case-only study will evaluate the clinical performance of a blood-based, cell-free DNA (cfDNA) methylation multi-cancer early detection (MCED) test in adults aged 50 to 74 years with confirmed invasive cancer or selected high-risk precancerous lesions/carcinoma in situ.
The study will primarily recruit patients who had no cancer-related symptoms before diagnosis. An additional tissue-of-origin (TOO) model optimization cohort will include patients with urothelial cancer, colorectal advanced adenoma, gastric high-grade dysplasia, or esophageal high-grade dysplasia, irrespective of symptom status.
研究概览
详细说明
Previous case-control studies have shown promising performance in patients with established cancer diagnoses. However, conventional case-control studies predominantly enroll symptomatic patients, whose tumor burden and circulating tumor DNA (ctDNA) levels may differ from those of asymptomatic patients, even at the same cancer stage. Consequently, the sensitivity and tissue-of-origin (TOO) accuracy observed in conventional case-control studies may not fully reflect test performance in the intended screening setting. Further evaluation in asymptomatic patients with cancer is therefore needed to better characterize the technical performance of MCED tests.
This multicenter, observational, case-only study aims to evaluate the performance of a cfDNA methylation-based MCED model in patients with asymptomatic cancers and selected high-risk precancerous lesions or carcinoma in situ. The study will also support targeted optimization of the TOO prediction model for selected disease categories.
Approximately 948 participants are planned for consent and pre-treatment blood sampling. MCED test results will not be disclosed to participants or treating investigators or used to guide clinical management. The study is expected to provide additional evidence on the technical performance of cfDNA methylation-based MCED testing in asymptomatic patients and to support further model development and clinical evaluation.
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients from hospitals: inpatient and outpatient
描述
Asymptomatic Cohort
Inclusion Criteria:
- Clinically and/or pathologically diagnosed with any one of the 13 invasive cancers including lung cancer, gastric cancer, etc., or diagnosed with high-risk precancerous lesions / carcinoma in situ corresponding to these 13 cancers.
- 50-74 years old.
- Self-reported absence of prespecified symptoms related to the corresponding cancer prior to diagnosis.
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Exclusion Criteria:
- Female subjects with self-reported pregnancy.
- Severe infection within 14 days before screening.
- Recipients of blood transfusion within 7 days prior to screen
- With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
- Other conditions judged by the investigator to render the subject ineligible for participation in this study.
TOO Model Optimization Cohort:
Inclusion Criteria:
- Clinically and/or pathologically diagnosed with any of the following diseases: urothelial carcinoma of the bladder, advanced colorectal adenomas, high-grade gastric intraepithelial neoplasia, or high-grade esophageal intraepithelial neoplasia
- 50-74 years old.
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures.
Exclusion Criteria:
- Female subjects with self-reported pregnancy.
- Severe infection within 14 days before screening.
- Recipients of blood transfusion within 7 days prior to screen
- With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
- Other conditions judged by the investigator to render the subject ineligible for participation in this study.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Asymptomatic Cohort
|
A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay. |
|
TOO Model Optimization Cohort
|
A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity of Cancer Signal Detection (CSD)
大体时间：6 months after the completion of enrollment
|
The proportion of participants with a positive CSD result among those with clinically and/or pathologically confirmed eligible diseases, calculated overall and by disease category, with corresponding 95% confidence intervals. |
6 months after the completion of enrollment
|
|
Accuracy of Tissue-of-Origin (TOO) Prediction
大体时间：6 months after the completion of enrollment
|
The proportion of CSD-positive participants whose predicted TOO category matches the clinically and/or pathologically confirmed disease site, calculated overall and by disease category, with corresponding 95% confidence intervals. |
6 months after the completion of enrollment
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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