EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 11
- 主要终点
- Test Sufficient Samples
研究概览
简要总结
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.
详细描述
The EMERALD study is a multi-center study (Protocol No. EXPT-MC-F-2024) designed to establish a clinical plasma repository for the training and clinical evaluation of the ExoPred deep learning software
The study protocol operates in three sequential phases to ensure data integrity and prevent algorithmic overfitting:
Phase 1 (Algorithm Training Stage): A minimum of 500 samples are analyzed to develop the algorithm and establish the initial clinical cut-off values, followed by a database lock.
Phase 2 (Algorithm Lock-Readiness Assessment): A minimum of 50 newly acquired unknown samples are evaluated to assess model robustness before the final algorithm is formally locked in the Technical File.
Phase 3 (Blinded Independent Stage): A minimum of 200 independent samples, strictly excluded from prior phases, are tested under strict blinding to evaluate finalized clinical sensitivity, specificity, and accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer.
- •Subjects who are willing and able to provide written informed consent.
- •Subjects who are willing and able to comply with the study requirements.
排除标准
- •Any history of cancer diagnosed and treated within 5 years prior to the date of consent.
- •Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis.
- •Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
- •Subjects who are pregnant or breastfeeding women.
- •Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months.
- •Subjects who are currently in active treatment for drug abuse.
- •Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study.
- •Unsuitable sample for testing due to contamination, hemolysis, etc.
研究组 & 干预措施
Lung Cancer
干预措施: EXoPred (Diagnostic Test)
Breast Cancer
干预措施: EXoPred (Diagnostic Test)
Colorectal Cancer
干预措施: EXoPred (Diagnostic Test)
Pancreatic Cancer
干预措施: EXoPred (Diagnostic Test)
Ovarian Cancer
干预措施: EXoPred (Diagnostic Test)
Control
干预措施: EXoPred (Diagnostic Test)
结局指标
主要结局
Test Sufficient Samples
时间窗: From date of enrollment up to 36 months
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
Evaluate Performance
时间窗: From date of enrollment up to 36 months
Test performance: diagnosis of multiple cancer, assessed by sensitivity. Test performance: diagnosis of multiple cancer, assessed by specificity. Test performance: diagnosis of multiple cancer, assessed by tissue of origin (TOO) accuracy.
次要结局
未报告次要终点