IGF::OT::IGF R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

75%以上的肺癌患者在晚期或转移时才被确诊，5年生存率<5%。 血液、尿液和其他体液中的一组microRNAs（miRNAs）被发现是肺癌的生物标志物。 因此，我们建议开发基于miRNA的低成本、非敏感性（需要<1 μ l血清）和快速响应的床旁（POC）芯片，其使用多路复用的细胞技术用于临床肺癌的早期诊断、预后和对治疗的响应。 在第一阶段，将使用非小细胞肺癌（NSCLC，约80%的肺癌病例）的约10种miRNA标准品开发无标记的超灵敏肺癌特异性细胞阵列，并将使用NSCLC和正常肺细胞系探索实用性。 将使用阵列确定来自约30名NSCLC患者和30名匹配的健康受试者的血清中的10种miRNA的水平，以验证NSCLC特异性miRNA特征用于临床使用。 在第二阶段，我们将使用miRNA细胞技术筛选数千名肺癌患者的血清，以确认肺癌miRNA签名并开发手指点刺试验。 我们还将开发用于其他癌症的miRNA纳米井技术。 我们将申请FDA批准用于临床癌症诊断的miRNA细胞设备。

Over 75% lung cancer patients are not diagnosed until at advanced or metastatic stage with <5% 5-year survival rate. A panel of microRNAs (miRNAs) in blood, urine and other body fluids were found to be lung cancer biomarkers. Thus, we propose to develop miRNA-based low-cost, untrasensitive (<1 ul serum needed) and fast responsive point-of-care (POC) chips using multiplex nanowell technology for early diagnosis, prognosis and response to therapy of lung cancer at clinics. During Phase I, label-free ultrasensitive lung cancer specific-nanowell arrays will be developed using ~10 miRNA standards for non-small cell lung cancer (NSCLC, ~80% of lung cancer cases), and utility will be explored using NSCLC and normal lung cell lines. Levels of the 10 miRNAs in sera from ~30 NSCLC patients and 30 matching healthy subjects will be determined using the arrays to verify NSCLC-specific miRNA signatures for clinical use. During Phase II, we will screen thousands of lung cancer patients' sera using the miRNA nanowell technology to confirm the lung cancer miRNA signatures and develop a finger prick test. We will also develop miRNA nanowell technologies for other cancers. We will apply for an FDA approval of the miRNA nanowell devices for cancer diagnosis at clinics.