Design. From July 2016 to June 2018, 36 women with symptomatic early pregnancy around 4-8 weeks of gestation were recruited into the study. Among them, there were 16 women with viable intrauterine pregnancy (VIP), 9 women with spontaneous abortion (SA), and 11 women of EP. Serum exosomal miRNAs were extracted and measured at the first prenatal visit. Statistical analysis was performed to determine the clinical utility of these biomarkers as single markers and as multimarker panels for EP. Results. Concentrations of miR-378d in serum exosomes were significantly higher in EP than in VIP and also SA group. As a single marker, miR-378d had the highest specificity of 64% at the sensitivity of 89.1%. Comparatively, both combined panels of hCG, progesterone, miR-100-5p and hCG, progesterone, and miR-215-5P yielded the specificity of 96%. Panels for all markers achieved the highest specificity of 80% at the sensitivity of 91%. Conclusions. Although further validation in large-scale prospective studies is necessary, our results suggest that serum exosomal miR-378d, miR-100-5p, and miR-215-5P are promising biomarkers for early EP.
Objectives UpRi is a first-in-class NaPi2b ADC with a novel scaffold-linker-payload that enables high drug-to-antibody ratio and controlled bystander effect. NaPi2b is a sodiumdependent phosphate transporter broadly expressed in highgrade serous ovarian cancer (HGSOC), with limited expression in normal tissues. Emerging UpRi data suggests a relationship between high NaPi2b expression and clinical activity. To determine if archive material would be sufficient to classify biomarker status, we evaluated NaPi2b expression in paired freshly biopsied and archive material from the Phase 1b study. Methods Two sample sets were evaluated for NaPi2b expression using an IHC assay. The first set (18 pairs) was procured from tissue banks, representing synchronous sampling of primary and metastatic lesions to establish a reference NaPi2b heterogeneity rate. The second set were matched metachronous samples (56 pairs) from the Phase 1b study, sampled prior to UpRi administration. Expression was shown as a tumor proportion score (TPS 75). Concordance rates and Kappa values were calculated. Results Synchronous primary and metastatic lesions from an archival tumor bank showed a concordance rate of 72%. When fresh biopsy samples from a clinical study cohort were compared to archival tissue from the same patient, 76% of NaPi2B high tumors in archival tissue were also high in fresh samples, regardless of the elapsed time between archival and fresh tissue samples. Conclusions UpRi is being evaluated in clinical trials, requiring either fresh or archival tissue for NaPi2b expression assessment. The high expression concordance rate seen suggests that NaPi2b remains consistent throughout chemotherapy treatment, supporting use of archival tissue for analysis.
As strategic assets for organizations, information systems (IS) have been adopted to enhance organizational knowledge performance. Based on the absorptive capacity perspective, we investigated intertwined relationships among IS adoption, organizational capabilities, IS-enabled absorptive capacity, and organizational knowledge performance. We empirically examined our model with survey data from 417 IS employees of 21 different state governments in the United States. We find that: (1) IS adoption does not directly generate IS-enabled absorptive capacity; (2) organizational capabilities positively affect IS-enabled absorptive capacity; (3) synergies arising from complementarity between IS adoption and organizational capabilities have a positive impact on IS-enabled absorptive capacity; and (4) IS-enabled absorptive capacity significantly drives manager and employee knowledge performance. This research enriches the understanding of the relationships among IS adoption, organizational capabilities, and organizational knowledge performance in U.S. public sectors.
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