Objective: Validation of uHear™ as a screening tool to detect hearing loss in older patients with cancer without a known diagnosis of presbycusis, as part of a Comprehensive Geriatric Assessment (CGA).
Materials and methods:Patients (≥ 70 years) with a histologically confirmed diagnosis of cancer, were enrolled at the time of CGA screening. Patients were evaluated by uHear™, which was compared to conventional audiometry as gold standard. We defined a pure-tone average (PTA) of ≥ 40 dB HL as the pass or fail screening cut-off. Validation of uHear™ was defined in terms of diagnostic accuracy through Receiver Operating Characteristics (ROC)-analysis. To accept uHear™, we estimated that the Area Under the ROC-curve (AUC) had to differ significantly from 0.50 with an AUC of at least 0.70. The Whispered Voice Test and Hearing Handicap Inventory for the Elderly were also administered.Results: Thirty-three patients consented for participation. In one patient, the results of one ear were excluded from the analysis as the patient was documented with a known hearing disorder in that ear. Significant hearing loss, defined by a PTA of ≥40 dB HL calculated from the air conduction thresholds at 0.5, 1.0 and 2.0 kHz, was found in 15.4% of tested ears. uHear™ showed excellent diagnostic accuracy with an AUC ± SE of 0.98 ± 0.14. It provided maximum sensitivity (100.0%) but poor specificity (36.4%) at our predefined cut-off score of ≥40 dB HL.
Keywords:Older cancer patients Comprehensive geriatric assessment Hearing loss⁎ Corresponding author at: General Hospital Groeninge, Cancer Center, Loofstraat 43, B-8500 Kortrijk, Belgium. Tel.: +32 56633900; fax: +32 56633909.E-mail address: Philip.Debruyne@azgroeninge.be (P.R. Debruyne). Conclusion: uHear™ can be implemented as a screening tool to detect hearing loss in older patients with cancer within a CGA.
A multicenter study was performed to determine an optimal workflow for liquid biopsy in a clinical setting. In total, 549 plasma samples from 234 non-small cell lung cancer (NSCLC) patients were collected. Epidermal Growth Factor Receptor (EGFR) circulating cell-free tumor DNA (ctDNA) mutational analysis was performed using digital droplet PCR (ddPCR). The influence of (pre-) analytical variables on ctDNA analysis was investigated. Sensitivity of ctDNA analysis was influenced by an interplay between increased plasma volume (p < 0.001) and short transit time (p = 0.018). Multistep, high-speed centrifugation both increased plasma generation (p < 0.001) and reduced genomic DNA (gDNA) contamination. Longer transit time increased the risk of hemolysis (p < 0.001) and low temperatures were shown to have a negative effect. Metastatic sites were found to be strongly associated with ctDNA detection (p < 0.001), as well as allele frequency (p = 0.034). Activating mutations were detected in a higher concentration and allele frequency compared to the T790M mutation (p = 0.003, and p = 0.002, respectively). Optimization of (pre-) analytical variables is key to successful ctDNA analysis. Sufficient plasma volumes without hemolysis or gDNA contamination can be achieved by using multistep, high-speed centrifugation, coupled with short transit time and temperature regulation. Metastatic site location influenced ctDNA detection. Finally, ctDNA levels might have further value in detecting resistance mechanisms.
Our results indicate that the Freund CDT can be used as an initial screening tool to detect elderly cancer patients in need of a more in-depth cognitive assessment within CGA, instead of the MMSE.
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