Multicentre prospective & retrospective remnant Biospecimen collection program for study and future biomedical research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To identify the panel of most sensitive and specific biomarkers amongst the 12 candidate protein biomarkers that can yield a sensitivity of more than 90%.
研究概览
简要总结
This is a retrospective, case-control exploratory study designed to evaluate the diagnostic accuracy of a novel panel of circulating blood biomarkers in differentiating lung cancer patients from healthy individuals. A total of 120 participants will be recruited, including 70 lung cancer patients (both treatment-naive and undergoing therapy) and 50 healthy volunteers. Blood samples will be analyzed using immunoassay to quantify biomarker levels, which will be processed through a clinical inference tool (VarSee) to generate diagnostic scores. The study aims to assess sensitivity, specificity, predictive values, and AUC-ROC of individual and combined biomarkers. This research intends to offer a non-invasive, cost-effective alternative to current diagnostic modalities like LDCT for early lung cancer detection in high-risk populations.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •newly diagnosed lung cancer patients with confirmed tissue biopsy and CT scan and no treatment or surgery before enrollment.
- •Inclusion criteria for cancer cohort.
排除标准
- •Pediatric lung cancer patients, patients with history of previous cancers.
结局指标
主要结局
To identify the panel of most sensitive and specific biomarkers amongst the 12 candidate protein biomarkers that can yield a sensitivity of more than 90%.
时间窗: At the baseline
To assess the sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC-ROC) of the biomarker panel for lung cancer diagnosis.
时间窗: At the baseline
To compare the diagnostic performance of individual biomarkers within the shortlisted panel and compare them with the entire panel.
时间窗: At the baseline
次要结局
- To assess the correlation between biomarker levels and tumor characteristics, such as tumor size, histological subtype, or stage of lung cancer.(At the baseline)
研究者
Dr Akash Patel
Shlok Superspecialty Care