We take extreme pleasure to uphold that Journal of Clinical Trials had a promising journey since its inception and is being hailed as a revolutionary in the industry of open access journals. We appreciatively give thanks to all our marvelous Authors, Reviewers, teamed with the assistance of our honorable Editorial board members has played a major role in our success for creating Clinical Trails 2019 the simplest ever!

https://www.longdom.org/open-access/current-challenges-in-clinical-trials.pdf

Current Challenges in Clinical Trials

Neuroendocrine neoplasm (NEN) is a comparatively rare tumor that has been considered indolent. Due to these characteristics, detailed epidemiological data have not been analyzed in Japan. To elucidate the present status of NEN diagnosis and treatment in Japan, we started a registry cohort study in January 2015.Patients pathologically diagnosed with NENs of the pancreas, gastrointestinal tract, lungs, bronchi, or thymus after January 2012 were enrolled in this registry after the date of ethics review committee approval in each hospital or institute. Follow-up was continued for enrolled patients.During 5 years of enrollment between January 2015 and December 2019, a total of 1526 participants from 63 departments were enrolled in this registry (mean, 305.2 participants/year), covering approximately 5.8% of the annual incidence of NENs in Japan. For pancreatic NEN, 41.9% of patients had metastasis and the dominant metastatic site was the liver, at twice the rate of lymph node metastasis in the current registry. In contrast, the frequency of lymph node metastasis from gastrointestinal (GI)-NEN was similar to that of the liver. The distribution of WHO 2019-based grades varied according to the primary site. Low-to-intermediate grade (G1-G2) was dominant for duodenal, jejunal/ileal, rectal, and pancreatic NENs, whereas high grade (G3 or NEC) was dominant for esophageal, stomach, and colon NENs. For PanNENs, G3 and NEC accounted only for 1.6% and 2.9%, respectively.These cohort data provide crucial information for clinical research to clarify the characteristics of NENs in Japan. 

/pdf/nationwide-registry-for-patients-with-neuroendocrine-19l6ci1z.pdf

Nationwide registry for patients with neuroendocrine neoplasm of pancreas, gastrointestinal tract, lungs, bronchi, or thymus in Japan

Introduction: Both the diagnosis and the treatment of patients with neuroendocrine neoplasm (NEN) have recently improved globally. Since little data has been presented on the current situation of NEN treatment in Japan, Japan Neuroendocrine Tumor Society (JNETS) established the Japan NEN Registry study and constructed a registry of Japanese NEN patients with a primary site of the pancreas gastrointestinal tract, lungs, bronchi, and thymus in order to clarify the current status of NEN treatment in Japan.
Methods and analysis: The Japan NEN Registry study is a large, multi-institutional prospective cohort study designed by JNETS to clarify actual clinical practice and corresponding outcomes for patients with pathologically diagnosed NENs. At enrollment, demographic characteristics, baseline values and survival event information are reported in an electronic case report form via website. The primary endpoint is overall survival time starting from the date of diagnosis, while the secondary endpoint is progression-free survival starting from the first date of each treatment.
Ethics and dissemination: This study is being conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Research.
The protocol of this cohort study was created in December 2014 and approved by the ethics review committee of Kyoto University Hospital (version 1.0 approval no. E2383, dated Jan 5, 2015). It was subsequently revised to collect treatment information and follow-up clinical outcomes in December 2018, and the ethics review committee of Kyoto University Hospital approved the protocol (Approval No. R1857-1, date April 19, 2019), and the individual institutional review boards of all participating facilities approved this study (TRIAL REGISTRATION: UMIN-CTR: UMIN000016380). The results of this study will be submitted to peer-reviewed international papers.
Trial registration: UMIN-CTR: UMIN000016380
Strengths and limitations of this study:
• This registration is proposed to provide real-time information on the status of NEN patients in Japan which has not been elucidated so far.
• We intend to prospectively collect information on treatments for these patients with corresponding outcomes.
• This study allows quantitative, descriptive, and comparative analyses, which will evaluate associations among risk factors, treatment, and outcomes for NEN in Japan.

https://www.longdom.org/open-access/study-protocol-of-the-japan-nen-registry-a-multicenter-prospective-registry-of-patients-with-pancreatic-gastrointestinal.pdf

Study Protocol of the Japan NEN Registry: A Multicenter, Prospective Registry of Patients with Pancreatic, Gastrointestinal, Pulmonary, Bronchial, and Thymic Neuroendocrine Neoplasm

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Study Protocol of the Japan NEN Registry: A Multicenter, Prospective Registry of Patients with Pancreatic, Gastrointestinal, Pulmonary, Bronchial, and Thymic Neuroendocrine Neoplasm