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Protocol
Oncology
Venous thromboembolism in patients with cancer: design and rationale of a multicentre, prospective registry (Cancer-VTE Registry)
  1. Yasuo Ohashi1,
  2. Masataka Ikeda2,
  3. Hideo Kunitoh3,
  4. Mitsuru Sasako4,
  5. Takuji Okusaka5,
  6. Hirofumi Mukai6,
  7. Keiichi Fujiwara7,
  8. Mashio Nakamura8,
  9. Tetsuya Kimura9,
  10. Kei Ibusuki9,
  11. Masato Sakon10
  1. 1 Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan
  2. 2 Division of Lower Gastrointestinal Surgery, Hyogo College of Medicine, Nishinomiya, Japan
  3. 3 Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan
  4. 4 Department of Multidisciplinary Surgical Oncology, Hyogo College of Medicine, Nishinomiya, Japan
  5. 5 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
  6. 6 Division of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan
  7. 7 Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan
  8. 8 Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan
  9. 9 Department of Medical Science, Daiichi Sankyo Co. Ltd, Tokyo, Japan
  10. 10 Department of Gastrointestinal Surgery, Osaka International Cancer Institute, Osaka, Japan
  1. Correspondence to Professor Yasuo Ohashi; ohashiy.00e{at}g.chuo-u.ac.jp

Abstract

Introduction Patients with cancer are at higher risk of venous thromboembolism (VTE) than the general population as the malignancy itself and treatment modalities, including medication and surgery, contribute to the risk of developing VTE. Furthermore, patients with cancer developing VTE have a worse prognosis than those without cancer. There are no multicentre prospective data on the occurrence and treatment of VTE in patients with cancer in Japan, and data on the outcomes, complications and incidence of VTE in these patients have not been reported. In addition, Japanese patients with cancer are traditionally treated with unfractionated heparin or warfarin; however, the use of direct oral anticoagulants, which became available in 2014, has not been sufficiently examined in this patient group. Therefore, this multicentre, prospective registry has been designed to capture VTE data from Japanese patients presenting with six cancer types.

Methods and analysis This registry will enrol 10 000 patients with colorectal, lung, stomach, breast, gynaecological (including endometrial, cervical, ovarian, fallopian tube and peritoneal) or pancreatic cancer between March 2017 and March 2019 and follow them for 1 year. We plan to collect data on the incidences of symptomatic VTE, bleeding events, stroke, systemic embolic events, incidental VTE requiring treatment in patients, overall survival and symptomatic VTE event-free survival.

Ethics and dissemination All patients will provide written informed consent. Data will remain anonymous and will be collected using an online electronic data capture system. Study protocol, amendments and informed consent forms will be approved by the institutional review board/independent ethics committee at each site prior to study commencement. Results will be disseminated at national meetings and published in peer-reviewed journals.

Trial registration number UMIN000024942.

  • venous thromboembolism
  • anticoagulant drugs
  • direct oral anticoagulants
  • deep vein thrombosis
  • pulmonary embolism
  • registries

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-018910

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    Footnotes

    • Contributors YO, MI, HK, MS, TO, HM, KF, MN, TK, KI and MS conceived and designed the study. YO, TK and KI drafted the protocol of the study and organised the study implementation. YO, MI, HK, MS, TO, HM, KF, MN, TK, KI and MS refined the study protocol and study implementation. All authors have read and approved the final version of the manuscript.

    • Funding This study is funded by Daiichi Sankyo, which initiated the study and was involved in the protocol development, selection and/or advice around selection of the contract research organisation, and in the statistical analysis plan development, and will be involved in the interpretation of results.

    • Disclaimer Daiichi Sankyo will not be directly involved in the data management, source data verification or the statistical analysis.

    • Competing interests All authors have received personal fees from Daiichi Sankyo during the conduct of study. KF has received research grants from Daiichi Sankyo. TK and KI are employees of Daiichi Sankyo.

    • Ethics approval Independent ethics committee/institutional review board at each site.

    • Provenance and peer review Not commissioned; externally peer reviewed.