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Cancer Sci ; 113(4): 1531-1534, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1779205


According to the current international guidelines, high-risk patients diagnosed with pathological T1 (pT1) colorectal cancer (CRC) who underwent complete local resection but may have risk of developing lymph node metastasis (LNM) are recommended additional intestinal resection with lymph node dissection. However, around 90% of the patients without LNM are exposed to the risk of being overtreated due to the insufficient pathological criteria for risk stratification of LNM. Circulating tumor DNA (ctDNA) is a noninvasive biomarker for molecular residual disease and relapse detection after treatments including surgical and endoscopic resection of solid tumors. The CIRCULATE-Japan project includes a large-scale patient-screening registry of the GALAXY study to track ctDNA status of patients with stage II to IV or recurrent CRC that can be completely resected. Based on the CIRCULATE-Japan platform, we launched DENEB, a new prospective study, within the GALAXY study for patients with pT1 CRC who underwent complete local resection and were scheduled for additional intestinal resection with lymph node dissection based on the standard pathologic risk stratification criteria for LNM. The aim of this study is to explore the ability of predicting LNM using ctDNA analysis compared with the standard pathological criteria. The ctDNA assay will build new evidence to establish a noninvasive personalized diagnosis in patients, which will facilitate tailored/optimal treatment strategies for CRC patients.

Circulating Tumor DNA , Colorectal Neoplasms , Circulating Tumor DNA/genetics , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Humans , Liquid Biopsy , Lymph Node Excision , Lymph Nodes/pathology , Lymphatic Metastasis/pathology , Neoplasm Recurrence, Local/pathology , Neoplasm Staging , Prospective Studies , Retrospective Studies , Risk Factors
Sex Med ; 9(3): 100366, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1575369


INTRODUCTION: Telemedicine has the potential to improve access to care; however, its utility in the field of sexual medicine remains in question. AIM: To examine the importance of video visits for the treatment of male sexual medicine at our academic center during the period of peak telemedicine use in April 2020. METHODS: We collected and compared deidentified data from all nonprocedure, adult outpatient encounters conducted as either office visits in April 2019 (n = 1,949) or video visits in April 2020 (n = 608). The primary International Classification of Diseases codes (ICD-10) labeled as diagnoses from all encounters were collected, with most encounters linked to several disease codes (n = 4,584). Demographic data were also collected. We performed comparative analyses on Stata (College Station, TX, USA) with significance set at α = .05. MAIN OUTCOME MEASURES: Disease codes were categorized based on their use and classification in urological care and the proportion that each category made up within the outpatient practice was calculated. RESULTS: In comparison to the office visits, which took place in April 2019, male sexual medicine visits in April 2020, during the peak of telemedicine use, made up a significantly larger overall share of our practice (P = .012), defined by relative rises in encounters pertaining to male hypogonadism, infertility, penile abnormalities, and testicular abnormalities. Outpatients seen over video visits were also younger than outpatients seen during the previous year over office visits (58.9 vs 60.8, P = .008). Further, race and ethnicity characteristics in the outpatient population were unaffected during the period of telemedicine use. CONCLUSIONS: During the period of historically high telemedicine use following the SARS-CoV-2 outbreak, encounters associated with male sexual medicine made up a significantly larger portion of our outpatient practice. Although the full influence of the COVID-19 pandemic cannot be delineated, our findings suggest telemedicine use is compatible with the field of sexual medicine. Rabinowitz MJ, Kohn TP, Ellimoottil C, et al. The Impact of Telemedicine on Sexual Medicine at a Major Academic Center During the COVID-19 Pandemic. Sex Med 2021;9:100366.

Cancer Sci ; 112(7): 2915-2920, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1294969


Adjuvant chemotherapy has reduced the risk of tumor recurrence and improved survival in patients with resected colorectal cancer. Potential utility of circulating tumor DNA (ctDNA) prior to and post surgery has been reported across various solid tumors. We initiated a new type of adaptive platform trials to evaluate the clinical benefits of ctDNA analysis and refine precision adjuvant therapy for resectable colorectal cancer, named CIRCULATE-Japan including three clinical trials. The GALAXY study is a prospectively conducted large-scale registry designed to monitor ctDNA for patients with clinical stage II to IV or recurrent colorectal cancer who can undergo complete surgical resection. The VEGA trial is a randomized phase III study designed to test whether postoperative surgery alone is noninferior to the standard therapy with capecitabine plus oxaliplatin for 3 months in patients with high-risk stage II or low-risk stage III colon cancer if ctDNA status is negative at week 4 after curative surgery in the GALAXY study. The ALTAIR trial is a double-blind, phase III study designed to establish the superiority of trifluridine/tipiracil as compared with placebo in patients with resected colorectal cancer who show circulating tumor-positive status in the GALAXY study. Therefore, CIRCULATE-Japan encompasses both "de-escalation" and "escalation" trials for ctDNA-negative and -positive patients, respectively, and helps to answer whether measuring ctDNA postoperatively has prognostic and/or predictive value. Our ctDNA-guided adaptive platform trials will accelerate clinical development toward further precision oncology in the field of adjuvant therapy. Analysis of ctDNA status could be utilized as a predictor of risk stratification for recurrence and to monitor the effectiveness of adjuvant chemotherapy. ctDNA is a promising, noninvasive tumor biomarker that can aid in tumor monitoring throughout disease management.

Circulating Tumor DNA/blood , Colorectal Neoplasms/blood , Neoplasm Recurrence, Local/blood , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Capecitabine/administration & dosage , Chemotherapy, Adjuvant , Colonic Neoplasms/blood , Colonic Neoplasms/genetics , Colonic Neoplasms/pathology , Colonic Neoplasms/therapy , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Colorectal Neoplasms/therapy , Double-Blind Method , Humans , Japan , Neoplasm Recurrence, Local/genetics , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/therapy , Oxaliplatin/administration & dosage , Prospective Studies , Pyrrolidines/administration & dosage , Thymine/administration & dosage , Trifluridine/administration & dosage