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    International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials
    (ELSEVIER SCIENCE INC, 2022-01-01) Smeltzer, Matthew P.; Scagliotti V, Giorgio; Wakelee, Heather A.; Mitsudomi, Tetsuya; Roy, Upal Basu; Clark, Russell C.; Arndt, Renee; Pruett, Clayton D.; Kelly, Karen L.; Ujhazy, Peter; Johnson, Melissa L.; Eralp, Yesim; Barrios, Carlos H.; Barlesi, Fabrice; Hirsch, Fred R.; Bunn, Paul A.; Coronavi, Int Assoc Study Lung Canc; Comm, Clinical Trials Steering
    Introduction: To evaluate the effects of the global coronavirus disease 2019 (COVID-19) pandemic on lung cancer trials, we surveyed investigators and collected aggregate enrollment data for lung cancer trials across the world before and during the pandemic. Methods: A Data Collection Survey collected aggregate monthly enrollment numbers from 294 global lung cancer trials for 2019 to 2020. A 64-question Action Survey evaluated the impact of COVID-19 on clinical trials and identified mitigation strategies implemented. Results: Clinical trial enrollment declined from 2019 to 2020 by 14\% globally. Most reductions in enrollment occurred in April to June where we found significant decreases in individual site enrollment (p = 0.0309). Enrollment was not significantly different in October 2019 to December of 2019 versus 2020 (p = 0.25). The most frequent challenges identified by the Action Survey (N = 172) were fewer eligible patients (63\%), decrease in protocol compliance (56\%), and suspension of trials (54\%). Patient-specific challenges included access to trial site (49\%), ability to travel (54\%), and willingness to visit the site (59\%). The most frequent mitigation strategies included modified monitoring requirements (47\%), telehealth visits (45\%), modified required visits (25\%), mailorder medications (25\%), and laboratory (27\%) and radiology (21\%) tests at nonstudy facilities. Sites that felt the most effective mitigation strategies were telehealth visits (85\%), remote patient-reported symptom collection (85\%), off-site procedures (85\%), and remote consenting (89\%).Conclusions: The COVID-19 pandemic created many challenges for lung cancer clinical trials conduct and enrollment. Mitigation strategies were used and, although the pandemic worsened, trial enrollment improved. A more flexible approach may improve enrollment and access to clinical trials, even beyond the pandemic.(c) 2022 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.
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    Detection of reactive oxygen metabolites in malignant and adjacent normal tissues of patients with lung cancer
    (BMC, 2013-01-01) Okur, Hacer Kuzu; Yuksel, Meral; Lacin, Tunc; Baysungur, Volkan; Okur, Erdal
    Background: Different types of reactive oxygen metabolites (ROMs) are known to be involved in carcinogenesis. Several studies have emphasized the formation of ROMs in ischemic tissues and in cases of inflammation. The increased amounts of ROMs in tumor tissues can either be because of their causative effects or because they are produced by the tumor itself. Our study aimed to investigate and compare the levels of ROMs in tumor tissue and adjacent lung parenchyma obtained from patients with lung cancer. Methods: Fifteen patients (all male, mean age 63.6 +/- 9 years) with non-small cell lung cancer were enrolled in the study. All patients were smokers. Of the patients with lung cancer, twelve had epidermoid carcinoma and three had adenocarcinoma. During anatomical resection of the lung, tumor tissue and macroscopically adjacent healthy lung parenchyma (control) that was 5 cm away from the tumor were obtained. The tissues were freshly frozen and stored at -20 degrees C. The generation of ROMs was monitored using luminol- and lucigenin-enhanced chemiluminescence (CL) techniques. Results: Both luminol (specific for. OH, H2O2, and HOCl-) and lucigenin (selective for O-2(center dot)) CL measurements were significantly higher in tumor tissues than in control tissues (P < 0.001). Luminol and lucigenin CL measurements were 1.93 +/- 0.71 and 2.5 +/- 0.84 times brighter, respectively, in tumor tissues than in the adjacent parenchyma (P = 0.07). Conclusion: In patients with lung cancer, all ROM levels were increased in tumor tissues when compared with the adjacent lung tissue. Because the increase in lucigenin concentration, which is due to tissue ischemia, is higher than the increase in luminol, which is directly related to the presence and severity of inflammation, ischemia may be more important than inflammation for tumor development in patients with lung cancer.