Novel prospective umbrella-type lung cancer registry study for clarifying clinical practice patterns: CS-Lung-003 study protocol

Introduction Conventional cancer registries are suitable for simple surveillance of cancer patients, including disease frequency and distribution, demographics, and prognosis; however, the collected data are inadequate to clarify comprehensively diverse clinical questions in daily practice. Methods We constructed an umbrella‐type lung cancer patient registry (CS‐Lung‐003) integrating multiple related prospective observational studies (linked studies) that reflect clinical questions about lung cancer treatment. The primary endpoint of this registry is to clarify daily clinical practice patterns in lung cancer treatment; a key inclusion criterion is pathologically diagnosed lung cancer. Under this registry, indispensable clinical items are detected in advance across all active linked studies and gathered prospectively and systematically to avoid excessive or insufficient data collection. Researchers are to input information mutually, irrespective of the relevance to each researcher's own study. Linked studies under the umbrella of the CS‐Lung‐003 registry will be updated annually with newly raised clinical questions; some linked studies will be newly created, while others will be deleted after the completion of the analysis. Enrollment began in July 2017. Discussion We successfully launched the umbrella‐type CS‐Lung‐003 registry. Under this single registry, researchers collaborate on patient registration and data provision for their own and other studies. Thus, the registry will produce results for multiple domains of study, providing answers to questions about lung cancer treatment raised by other researchers. Through such analysis of each linked study, this registry will contribute to the comprehensive elucidation of actual daily practice patterns in lung cancer treatment. Key points CS‐Lung‐003 registry directly integrates multiple linked studies created under the umbrella of this cancer registry to solve various clinical questions regarding daily practice patterns of lung cancer treatment

Visualization of the radiofrequency lesion after pulmonary vein isolation using delayed enhancement magnetic resonance imaging fused with magnetic resonance angiography

AbstractBackgroundThe radiofrequency (RF) lesions for atrial fibrillation (AF) ablation can be visualized by delayed enhancement magnetic resonance imaging (DE-MRI). However, the quality of anatomical information provided by DE-MRI is not adequate due to its spatial resolution. In contrast, magnetic resonance angiography (MRA) provides similar information regarding the left atrium (LA) and pulmonary veins (PVs) as computed tomography angiography. We hypothesized that DE-MRI fused with MRA will compensate for the inadequate image quality provided by DE-MRI.MethodsDE-MRI and MRA were performed in 18 patients who underwent AF ablation (age, 60±9 years; LA diameter, 42±6mm). Two observers independently assessed the DE-MRI and DE-MRI fused with MRA for visualization of the RF lesion (score 0–2; where 0: not visualized and 2: excellent in all 14 segments of the circular RF lesion).ResultsDE-MRI fused with MRA was successfully performed in all patients. The image quality score was significantly higher in DE-MRI fused with MRA compared to DE-MRI alone (observer 1: 22 (18, 25) vs 28 (28, 28), p<0.001; observer 2: 24 (23, 25) vs 28 (28, 28), p<0.001).ConclusionsDE-MRI fused with MRA was superior to DE-MRI for visualization of the RF lesion owing to the precise information on LA and PV anatomy provided by DE-MRI

Edoxaban for 12 Months Versus 3 Months in Cancer Patients With Isolated Distal Deep Vein Thrombosis (ONCO DVT study): An Open-label, Multicenter, Randomized Clinical Trial

Background: The optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis (DVT) in patients with cancer is clinically relevant, but the evidence is lacking. The prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events, however, it could also increase the risk of bleeding. Methods: In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 60 institutions in Japan, we randomly assigned cancer patients with isolated distal DVT, in a 1-to-1 ratio, to receive either a 12-month or 3-month edoxaban treatment. The primary endpoint was a composite of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months, according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that a 12-month edoxaban treatment was superior to a 3-month edoxaban treatment with respect to the primary endpoint. Results: From April 2019 through June 2022, 604 patients were randomized, and after excluding 3 patients who withdrew consent, 601 patients were included in the intention-to-treat population: 296 patients in the 12-month edoxaban group and 305 patients in the 3-month edoxaban group. The mean age was 70.8 years, 28% of the patients were men, and 20% of the patients had symptoms of DVT at baseline. The primary endpoint of a symptomatic recurrent VTE event or VTE-related death occurred in 3 of the 296 patients (1.0%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 0.13; 95% CI, 0.03 to 0.44). The major secondary endpoint of major bleeding occurred in 28 of the 296 patients (9.5%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 1.34; 95% CI, 0.75 to 2.41). The prespecified subgroups did not affect the estimates on the primary endpoint. Conclusions: In cancer patients with isolated distal DVT, 12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death

Visualizing radiofrequency lesions using delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation: A modification of the method used by the University of Utah group

Background: Atrial tissue fibrosis has previously been identified using delayed-enhancement MRI (DE-MRI) in patients with atrial fibrillation (AF). Although the clinical importance of DE-MRI is well recognized, the visualization of atrial fibrosis and radiofrequency (RF) lesions has still not been achieved in Japan, primarily because of the differences in contrast agents, volume-rendering tools, and technical experience. The objective of this study was to visualize RF lesions by using commercially available tools. Methods: DE-MRI was performed in 15 patients who had undergone AF ablation (age, 59±4 years, left atrium diameter, 40±2 mm). Specific parameters for MR scanning obtained from previous reports were modified. Results: Of the 15 images, the images of three patients were uninterpretable owing to low image quality. RF lesions could be visualized in 8 (67%) of the 12 patients. Conclusions: In the current study, we successfully demonstrated that RF lesions could be visualized in Japanese patients using DE-MRI, although only commercially available tools were used