Hybrid Bladder Phantom to Validate Next-Generation Optical Wearables for Neurogenic Bladder Volume Monitoring.

PURPOSE: The development of optics-based wearables for bladder volume monitoring has emerged as a significant topic in recent years. Given the innovative nature of this technology, there is currently no bladder phantom available to effectively validate these devices against more established gold standards, such as ultrasound. In this study, we showcase and demonstrate the performance of our hybrid bladder phantom by using an optical device and making comparisons with ultrasound. METHODS: A series of validation tests, including phantom repeatability, ultrasound scanning, and an optical test, were performed. A near-infrared optical device was utilized to conduct diffuse optical spectroscopy (DOS). Machine learning models were employed to construct predictive models of volume using optical signals. RESULTS: The size and position of an embedded balloon, serving as an analog for the bladder, were shown to be consistent when infused with 100 mL to 350 mL of water during repeatability testing. For DOS data, we present 7 types of machine learningbased models based on different optical signals. The 2 best-performing models demonstrated an average absolute volume error ranging from 12.7 mL to 19.0 mL. CONCLUSION: In this study, we introduced a hybrid bladder phantom designed for the validation of near-infrared spectroscopy-based bladder monitoring devices in comparison with ultrasound techniques. By offering a reproducible and robust validation tool, we aim to support the advancement of next-generation optical wearables for bladder volume monitoring.

Advancing Patient Care: Innovative Use of Near-Infrared Spectroscopy for Monitoring Urine Volume in Neurogenic Bladder.

PURPOSE: Current guidelines recommend clean intermittent catheterization (CIC) at regular time intervals for patients with spinal cord injuries; however, many patients experience difficulties. Performing time-based CIC outside the home is a significant burden for patients. In this study, we aimed to overcome the limitations of the current guidelines by developing a digital device to monitor bladder urine volume in real-time. METHODS: The optode sensor is a near-infrared spectroscopy (NIRS)-based wearable device intended to be attached to the skin of the lower abdomen where the bladder is located. The sensor's primary function is to detect changes in urine volume within the bladder. An in vitro study was conducted using a bladder phantom that mimicked the optical properties of the lower abdomen. To validate the data in the human body at the proof-of-concept level, one volunteer attached the device to the lower abdomen to measure the light intensity between the first voiding and immediately before the second voiding. RESULTS: The degree of attenuation at the maximum test volume was equivalent across experiments, and the optode sensor with multiplex measurements demonstrated robust performance for patient diversity. Moreover, the symmetric feature of the matrix was deemed a potential parameter for identifying the accuracy of sensor localization in a deep-learning model. The validated feasibility of the sensor showed almost the same results as an ultrasound scanner, which is routinely used in the clinical field. CONCLUSION: The optode sensor of the NIRS-based wearable device can measure the urine volume in the bladder in real-time.

Comparison of GenesWell BCT Score With Oncotype DX Recurrence Score for Risk Classification in Asian Women With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer.

Introduction: The GenesWell Breast Cancer Test (BCT) is a recently developed multigene assay that predicts the risk of distant recurrence in patients with early breast cancer. Here, we analyzed the concordance of the BCT score with the Oncotype DX recurrence score (RS) for risk stratification in Asian patients with pN0-N1, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Methods: Formalin-fixed, paraffin-embedded breast cancer tissues previously analyzed using the Oncotype DX test were assessed using the GenesWell BCT test. The risk stratification by the two tests was then compared. Results: A total of 771 patients from five institutions in Korea were analyzed. According to the BCT score, 527 (68.4%) patients were classified as low risk, and 244 (31.6%) as high risk. Meanwhile, 134 (17.4%), 516 (66.9%), and 121 (15.7%) patients were categorized into the low-, intermediate-, and high-risk groups, respectively, according to the RS ranges used in the TAILORx. The BCT high-risk group was significantly associated with advanced lymph node status, whereas no association between RS risk groups and nodal status was observed. The concordance between the two risk stratification methods in the overall population was 71.9% when the RS low-risk, and intermediate-risk groups were combined into one group. However, poor concordance was observed in patients aged ≤50 years and in those with lymph node-positive breast cancer. Conclusions: The concordance between the BCT score and RS was low in women aged ≤50 years or with lymph node-positive breast cancer. Further studies are necessary to identify more accurate tests for predicting prognosis and chemotherapy benefit in this subpopulation.

Efficacy of an RNA-based multigene assay with core needle biopsy samples for risk evaluation in hormone-positive early breast cancer.

BACKGROUND: Gene expression profiling provides key information for prognosis of breast cancer to establish treatment strategy. However, the genetic assessment should be available before induction of treatment to be useful for clinical practice. To evaluate the reliability of using needle biopsy samples for gene assays, we compared gene-expression profiling results between core needle biopsy (CNB) samples and surgical specimens in breast cancer. METHODS: Thirty-one paired, formalin-fixed, paraffin-embedded CNB and surgical specimen samples were selected from patients with hormone receptor-positive breast cancer. Total RNA was extracted from the samples and the risk classifications based on GenesWell BCT scores were compared. RESULTS: The BCT scores correlated between CNB samples and surgical specimens of hormone receptor-positive breast cancer (Pearson r = 0.66). The overall concordance rate of risk classification (high/low risk) was 83.9%. However, when the breast cancer does not contain intratumoral microcalcification, the concordance rate increased as 92.0%. And, when the breast cancer formed a solitary nodule (non-multifocal), the concordance rate increased up to 95.8%. CONCLUSION: Risk classification using the GenesWell BCT multigene kit with CNB samples could be considered reliable, when the breast cancer is a solitary nodule without intratumoral microcalcification. Such genetic profiling results should be helpful for establishing a treatment plan for hormone receptor-positive breast cancer before treatment induction.

Only estrogen receptor "positive" is not enough to predict the prognosis of breast cancer.

PURPOSE: Beginning in 2018, biomarkers including estrogen receptor (ER) status were incorporated in the 8th AJCC staging system. ER expression levels were not considered in these changes. We hypothesized that the levels of ER expression could affect the prognosis of breast cancer. METHODS: A retrospective review was conducted to identify all female patients with invasive breast cancer between 2003 and 2012. ER negative (group I), weakly ER-positive (group II), and strongly ER-positive (group III) were defined as Allred total scores of 0-2, 3-5, and 6-8, respectively. We examined a multigene panel, designated the BCT score, which is a newly developed prognostic model for predicting the risk of a distant metastasis. RESULTS: Among the 4949 patients enrolled in this study, 1310 (26.5%), 361 (7.3%), and 3277 (66.2%) were categorized as group I, II, and III, respectively. Median F/U duration was 57.8 months. Compared to group III, patients in group II were younger, had larger tumors, and were also more likely to have PR-negative tumors, HER-2 amplification, high Ki-67, and high nuclear grade. Between group II and III, there was a significant difference in OS (P = 0.0764, 0.909, and 0.010, respectively). After adjusting for additional factors that may affect OS, the HR for OS showed higher in group II than in group III. The baseline median BCT score indicated that lower ER expression was associated with significantly higher BCT score (P < 0.0001) and significantly more likely to have high risk group (P < 0.0001) relative to higher levels of ER expression group. CONCLUSION: ER expression levels affect the prognosis of breast cancer. The risk for patients with weakly ER-positive breast cancer should not be underestimated.

Identification of 2-methylthio cyclic N6-threonylcarbamoyladenosine (ms2ct6A) as a novel RNA modification at position 37 of tRNAs.

Transfer RNA modifications play pivotal roles in protein synthesis. N6-threonylcarbamoyladenosine (t6A) and its derivatives are modifications found at position 37, 3΄-adjacent to the anticodon, in tRNAs responsible for ANN codons. These modifications are universally conserved in all domains of life. t6A and its derivatives have pleiotropic functions in protein synthesis including aminoacylation, decoding and translocation. We previously discovered a cyclic form of t6A (ct6A) as a chemically labile derivative of t6A in tRNAs from bacteria, fungi, plants and protists. Here, we report 2-methylthio cyclic t6A (ms2ct6A), a novel derivative of ct6A found in tRNAs from Bacillus subtilis, plants and Trypanosoma brucei. In B. subtilis and T. brucei, ms2ct6A disappeared and remained to be ms2t6A and ct6A by depletion of tcdA and mtaB homologs, respectively, demonstrating that TcdA and MtaB are responsible for biogenesis of ms2ct6A.

Nucleoside Analysis by Hydrophilic Interaction Liquid Chromatography Coupled with Mass Spectrometry.

RNA molecules contain a wide variety of chemical modifications that cannot be deduced from the genomic sequence. RNA modifications confer a chemical diversity to simple RNA molecules, enabling a greater variety of biological functions. To detect RNA modifications, highly sensitive analytical tools are required. Liquid chromatography/mass spectrometry (LC/MS) has been playing a vital role in analyzing minor modified nucleosides in RNA specimens from various sources. Reverse-phase chromatography (RPC) has been used for LC/MS for a long time because RPC is compatible with electrospray ionization (ESI) MS. However, RPC is not always suitable for detecting hydrophilic or polar nucleosides. We here describe a different mode of LC/MS for detecting RNA modifications using hydrophilic interaction liquid chromatography (HILIC). HILIC/ESI-MS is a valuable alternative for profiling modified nucleosides.