Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials.

Background: There has been an increasing requirement for fresh tumor tissue to enroll in clinical trials in order to look for specific biomarkers. This has been shown to increase screening duration and increase screen failure rates. It was important to corroborate these results in other centers. Methods: This study is a non-randomized retrospective analysis of patients in one subset of patients seen by research nurses who operated in the standard head/neck and lung team not including patients in the phase 1 program. All patients were enrolled in clinical trials from January 16, 2013 to May 28, 2018 at USC Norris Comprehensive Cancer Institute in Los Angeles. Patients who were required to give fresh research biopsies prior to intervention were part of the research biopsy group. Results: In total, 76 patients were analyzed in this study. Thirty-three patients were in the research biopsygroup and 43 patients were in the no biopsy group. Trials that required a fresh biopsy had a longer median screening duration (30 vs. 14 days) than trials that did not require a biopsy (p < 0.0001). Conclusions: Our study shows that requiring biopsies prior to clinical trial treatment results in a statistically significant delay in treatment. The informed consent forms that were part of clinical trials involving mandatory research biopsies did not reflect this delay in treatment. However, these delays did not result in a statistically significant decrease in number of days on trial or days until progression of disease.

ST segment elevation myocardial infarction in patients hospitalized for non-cardiac conditions.

BACKGROUND: Timely use of primary percutaneous coronary intervention (PCI) is the standard of care for patients with ST segment elevation myocardial infarction (STEMI). Most patients with STEMI present via emergency medical services or self-transport to the emergency department (ED) and relatively little is known about the minority of patients that develop STEMI while hospitalized for non-cardiac conditions. The objective of this study was to analyze treatment times and clinical outcome for in-hospital STEMI patients. METHODS: Two-hundred fifty-five patients with STEMI treated at Keck Medical Center of USC and Los Angeles County USC Medical Center from January, 2009 to December, 2013 were retrospectively analyzed. Demographics, treatment time intervals and clinical outcome were collected. Patients arriving via the ED (ED STEMI Group, n=228; 89%) were compared to patients that developed in-hospital STEMI (In-hospital STEMI Group, n=27; 11%). RESULTS: Patients with in-hospital STEMI were similar in age, gender and associated medical conditions to ED STEMI patients. In-hospital STEMI patients were less likely to present with chest pain compared to ED STEMI patients, 5% vs. 79%, respectively, p<0.0001. Time from first abnormal electrocardiogram to device was 195±202min for in-hospital STEMI Group compared to door to device time of 88±64min for ED STEMI Group, p<0.001. Length of hospital stay was significantly longer for in-hospital STEMI Group compared to ED STEMI Group, 13±10 vs. 6.8±7.8days, respectively, p<0.001. In-hospital mortality was significantly higher for the in-hospital STEMI Group compared to the ED STEMI Group, 37% vs. 7%, respectively, p<0.001. CONCLUSIONS: In-hospital STEMI patients have significant treatment delays and worse clinical outcome compared to STEMI patients that present via the emergency department. Additional efforts are required to promptly identify in-hospital patients that develop STEMI.

Older mothers follow conservative strategies under predator pressure: the adaptive role of maternal glucocorticoids in yellow-bellied marmots.

When the maternal environment is a good predictor of the offspring environment, maternal glucocorticoid (GC) levels might serve to pre-program offspring to express certain phenotypes or life-history characteristics that will increase their fitness. We conducted a field study to assess the effects of naturally occurring maternal GC levels on their offspring in yellow-bellied marmots (Marmota flaviventris) subjected to different predator pressures. Maternal fecal corticosteroid metabolites (FCM) were positively correlated with predator pressure. Predators had both direct and indirect effects on pups. We found that older mothers with higher FCM levels had smaller and female-biased litters. Moreover, sons from older mothers with high FCM levels dispersed significantly more than those from older mothers with low FCM levels, whereas the opposite pattern was found in pups from younger mothers. These age-related effects may permit females to make adaptive decisions that increase their pups' fitness according to their current situation.