A prospective, interventional, single center study to correlate outcomes using OncoPredikt, an (AI-enabled platform) to predict genomic signatures from histopathological images in lung adenocarcinoma patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- OncoPredikt-based prediction of lung panel gene signature mutation status can be accurately performed on diagnostic H&E slides potentially yielding results quickly and affordably, even when limited tissue is available for testing, thus, providing a reliable and accurate screening tool to predict lung panel gene mutations.
研究概览
简要总结
This study focuses on the application of the OncoPredikt AI platform for predicting and correlating genomic signatures in lung cancer from histopathological lung biopsy slides. Lung cancer, the most commonly reported cancer worldwide, accounted for approximately 2.2 million new cases and 1.8 million deaths in 2020. Molecular classification of lung cancer, particularly the detection of specific mutations in genes like EGFR, BRAF, KRAS, and others, has advanced targeted therapeutic strategies. The study design is a prospective, interventional, single-center approach with a sample size of 52 cases and having study duration for patient recruitement is 12 months. It includes patients with confirmed lung cancer diagnoses and available Next-Generation Sequencing (NGS) reports, specifically for those with or without mutations in a set of key genes. The exclusion criterion focuses on patients without lung adenocarcinoma with a biomarker. The study will record various data parameters, including demographic details, cancer stage at diagnosis, mutation status, treatment details (chemotherapy, surgery, targeted therapy, radiotherapy, and immunotherapy), and the interpretation from the OncoPredikt AI model. The primary objective is to evaluate the accuracy of OncoPredikt in predicting lung panel gene signature mutations using diagnostic H&E slides, potentially offering a quicker and more cost-effective screening tool, even when tissue availability is limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients whose NGS (conventional testing) reports are available with confirmed diagnosis of Lung cancer with or without mutation status in the listed genes.
- •(KRAS, BRAF, EGFR, RET, ALK, ROS1, MET, STK11, ERBB2, NTRK mutations).
- •Patients whose Lung biopsy H&E slides or tissue biopsy slide is available.
- •Patients who would be willing to participate voluntarily.
排除标准
- •Patients who do not have lung adenocarcinoma with a biomarker.
结局指标
主要结局
OncoPredikt-based prediction of lung panel gene signature mutation status can be accurately performed on diagnostic H&E slides potentially yielding results quickly and affordably, even when limited tissue is available for testing, thus, providing a reliable and accurate screening tool to predict lung panel gene mutations.
时间窗: 15 days
次要结局
未报告次要终点
研究者
Dr Nirmal Raut
Bhaktivedanta Hospital and Research Institute
