Publications by authors named "Gerard J Davis"

Article Synopsis
  • The study aimed to improve colorectal cancer (CRC) screening by developing a tailored algorithm that combines the fecal immunochemical test (FIT) with blood test results and patient age to better identify individuals needing a colonoscopy.
  • The research involved 1977 participants from Denmark who were FIT-positive and examined eight blood-based biomarkers, discovering that the new algorithm outperformed the traditional FIT-only model in accurately distinguishing between CRC and non-CRC cases.
  • The results indicated that using the combined algorithm could enhance patient selection for colonoscopy, potentially reducing unnecessary procedures and improving healthcare efficiency.
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Background: Diagnosis of liver disease at earlier stages can improve outcomes and reduce the risk of progression to malignancy. Liver biopsy is the gold standard for diagnosis of liver disease, but is invasive and sample acquisition errors are common. Serum biomarkers for liver function and fibrosis, combined with patient factors, may allow for noninvasive detection of liver disease.

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Background: Fecal Immunochemical Test (FIT) is widely used in population-based screening for colorectal cancer (CRC). This had led to major challenges regarding colonoscopy capacity. Methods to maintain high sensitivity without compromising the colonoscopy capacity are needed.

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Objectives: To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument.

Methods: Contrived positive and negative specimens and de-identified nasal and nasopharyngeal specimens in transport media were used to evaluate specimen and reagent on-board stability, assay analytical performance and interference, and clinical performance.

Results: TCID50/mL values were similar for specimens in various transport media.

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The analysis of big healthcare data has enormous potential as a tool for advancing oncology drug development and patient treatment, particularly in the context of precision medicine. However, there are challenges in organizing, sharing, integrating, and making these data readily accessible to the research community. This review presents five case studies illustrating various successful approaches to addressing such challenges.

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Big data in healthcare can enable unprecedented understanding of diseases and their treatment, particularly in oncology. These data may include electronic health records, medical imaging, genomic sequencing, payor records, and data from pharmaceutical research, wearables, and medical devices. The ability to combine datasets and use data across many analyses is critical to the successful use of big data and is a concern for those who generate and use the data.

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Early detection of lung cancer allows for earlier stage treatment initiation and improved patient prognosis. This report focuses on utilization of combining patient demographic information with non-invasive biomarkers and their potential ability to predict risk of malignancy of nodules. A pilot study cohort of 141 subjects with IPNs (105 stage I cancer and 36 benign nodules) were collected by RUMC.

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Background: Non-invasive biomarkers are needed to improve management of indeterminate pulmonary nodules (IPNs) suspicious for lung cancer.

Methods: Protein biomarkers were quantified in serum samples from patients with 6-30 mm IPNs (n = 338). A previously derived and validated radiomic score based upon nodule shape, size, and texture was calculated from features derived from CT scans.

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Malnutrition and sarcopenia commonly overlap and contribute to adverse health outcomes. Previously, chronic supplementation with two oral nutritional supplements (ONS), control (C) and experimental ONS enriched with protein, vitamin D and β-hydroxy β-methylbutyrate (HMB) (E), improved muscle strength and quality in malnourished sarcopenic older adults, with E demonstrating early strength benefits at 12 weeks. To understand the underlying biological mechanisms contributing to the observed early strength benefits of E, we examined serum biomarker changes in response to 12-week supplementation.

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Background: Blood-based biomarkers used for colorectal cancer screening need to be developed and validated in appropriate screening populations. We aimed to develop a cancer-associated protein biomarker test for the detection of colorectal cancer in a screening population.

Methods: Participants from the Danish Colorectal Cancer Screening Program were recruited.

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Objectives: Corticotropin is notorious for its instability. Whereas several studies have investigated its short-term stability in plasma following venous blood sampling, studies on long-term stability are lacking. Here we investigated the long-term storage stability of corticotropin in ethylenediaminetetraacetic acid containing plasma.

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Background: Lean mass (LM) loss during extended bed rest contributes to long term functional decline in older adults. Identifying blood biomarkers that predict a hospitalized individual's risk of losing LM could allow for timely intervention.

Methods: LM from 19 healthy subjects (age 60-76 y, 4 males, 15 females), who were confined to 10 days of complete bed rest, was measured pre- and post-bed rest.

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Introduction: Blood-based, cancer-associated biomarkers are susceptible to a variety of well-known preanalytical factors. The influence of bowel preparation before a diagnostic colonoscopy on biomarker levels is, however, poorly investigated. The present study assessed the influence of bowel preparation on colorectal cancer-associated biomarkers.

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Introduction: Colorectal cancer (CRC) is the third most common cancer in the U.S. Early detection of CRC can substantially increase survival rates.

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Background: The biomarkers alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist-II (PIVKA-II) may be useful for detecting early-stage hepatocellular carcinoma (HCC). We evaluated the performance of AFP and PIVKA-II levels, alone and in combination with clinical factors, for the early detection of HCC.

Methods: In a case-control study, serum AFP and PIVKA-II were measured using the ARCHITECT immunoassay analyzer system in a cohort of 119 patients with HCC, 215 patients with non-malignant liver disease, and 34 healthy subjects.

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Background: Dipeptidyl peptidase-4 (DPP-4) may be a suitable biomarker to identify people with severe asthma who have greater activation of the interleukin-13 (IL-13) pathway and may therefore benefit from IL-13-targeted treatments. We report the analytical performance of an Investigational Use Only immunoassay and provide data on the biological range of DPP-4 concentrations.

Methods: We assessed assay performance, utilising analyses of precision, linearity and sensitivity; interference from common endogenous assay interferents, and from asthma and anti-diabetic medications, were also assessed.

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Background: Periostin is being investigated as a potential biomarker for T-helper-2 (Th2)-driven asthma or eosinophilic inflammation and may help to identify patients more likely to benefit from interleukin-13-targeted treatments. We report the development and analytic performance of the investigational use only ARCHITECT Periostin Immunoassay, a new automated assay developed to detect serum periostin concentrations.

Methods: We assessed assay performance in terms of precision, sensitivity, linearity, interference from classical immunoassay interferents and representatives of common asthma medications, specimen handling, and isoform reactivity.

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Background: Frequently, subjects offered colonoscopy due to symptoms of colorectal neoplasia are diagnosed with diverticula. The symptoms may, however, also be related to extra-colonic neoplasia. The present retrospective study evaluated a possible association between increased levels of predefined biomarkers in subjects diagnosed with diverticula and risk of developing a primary malignant disease.

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Article Synopsis
  • The study aimed to evaluate placental growth factor as a potential biomarker for predicting the effectiveness of motesanib in treating advanced nonsquamous non-small-cell lung cancer.
  • In a phase 2 study, significant overall survival was observed in patients with a notable increase in placental growth factor after treatment, but these results did not translate into a phase 3 trial, which failed to find any survival benefit linked to the biomarker.
  • The findings highlight difficulties in applying promising phase 2 biomarker findings to larger phase 3 trials successfully.
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Tissue inhibitor of metalloproteinases-1 (TIMP-1) plays a pivotal role in tissue remodeling processes, such as inflammation, wound healing and cancer invasion. Experimental results have pointed to a role in angiogenesis, cell proliferation, apoptosis and in malignant transformation. In clinical investigations high tumor tissue or plasma levels of TIMP-1 have been shown to have a strong and independent association with shorter survival time for breast and colorectal cancer patients, respectively.

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