UMIN-CTR Clinical Trial

Basic information
Public title	Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry
Acronym	Cancer-VTE Registry
Scientific Title	Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry
Scientific Title:Acronym	Cancer-VTE Registry
Region	Japan

Condition
Condition	colon cancer, lung cancer, gastric cancer, breast cancer, gynecologic cancer, pancreatic cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is intended to clarify the frequency of intercurrent of venous thromboembolism (VTE), actual condition of VTE treatment and its prognosis and to identify background factor related with VTE events in cancer patients, in addition clarify optimal medical attention population and usage for Direct Oral Anti Coagulant (DOAC) treatment.
Basic objectives2	Others
Basic objectives -Others	Evaluate a variety of clinical questions between cancer and VTE
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Baseline frequency of intercurrent of VTE at the time of VTE screening (2) Observation period (one year) incidence of symptomatic VTE incidence of bleeding events
Key secondary outcomes	Incidence of brain infarction/ systemic embolism Survival VTE related mortality rate and bleeding related mortality rate Brain infarction related mortality rate and systemic embolism related mortality rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)20 years old or older at written informed consent. (2) Diagnosed with any one of the following: colorectal cancer, lung cancer (small cell lung cancer, and non-small cell lung cancer), gastric cancer, breast cancer, gynecological cancer (endmetrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer), or pancreatic cancer (both initial and/or recurrence). Except active double cancer (synchronous double cancer, and metachronous double cancer with a disease-free period within 5 years) patients but patients with intramucosal cancer can be enrolled. (3) Planned to undergo drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or surgery. For recurrence cases, patients who received drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or underwent surgery at initial occurrence can be enrolled. (4) Carried out VTE screening (lower extremities venous ultrasound) within 2 months before enrollment and before the cancer treatment. If D-dimer value after the diagnosis of cancer is <=1.2 microgram/mL, VTE screening is not required. (5) Stage II to IV; for gynecological cancer, Stage I to IV and for lung cancer, Stage IB to IV. (6) Expected survival after enrollment must be >=6 months; for pancreatic cancer, >=3 months. (7) Eastern Cooperative Oncology Group (ECOG) Performance Status grade must be 0-2; for pancreatic cancer, 0-1. (8) Informed consent in writing given freely by the patients themselves for participation in the survey of this study.
Key exclusion criteria	A patient who is inappropriate as a subject of the study judged by investigator.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Ohashi
Organization	Chuo University
Division name	Department of science and engineering
Zip code	112-8551
Address	1-13-27Kasuga Bunkyoku Tokyo
TEL	03-3817-1715
Email	ohashiy.00e@g.chuo-u.ac.jp

Public contact
Name of contact person	1st name Secretariat Middle name Last name Cancer-VTE Registry
Organization	EPS Corporation
Division name	Clinical Research Center
Zip code	162-0814
Address	6-29 Ogawacho Shinjukuku Tokyo
TEL	03-5946-8264
Homepage URL
Email	epcr-vtenews@eps.co.jp

Sponsor
Institute	Medical Science Department Daiichi Sankyo Company, Limited.
Institute
Department

Funding Source
Organization	Medical Science Department Daiichi Sankyo Company, Limited. 3-5-1 Nihonbashi-honcho Chuo-ku, Tokyo 103-8426
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Non-Profit Organization MINS Research Ethics Committee
Address	5-20-9-401 Mita, Minato-ku, Tokyo
Tel	03-6416-1868
Email	npo-mins@j-irb.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター中央病院（東京）、国立がん研究センター東病院（千葉県）、大阪府立成人病センター（大阪）、国立病院機構大阪医療センター（大阪）、兵庫医科大学（兵庫）、日本赤十字社医療センター（東京）、埼玉医科大学国際医療センター（埼玉）他約150施設

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 10 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5988100/
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.thromres.2021.09.012
Number of participants that the trial has enrolled	10202
Results	The cumulative incidences of symptomatic VTE, bleeding, and all-cause death one year after enrollment were 0.5%, 1.4%, and 12.2%, respectively. Symptomatic VTE was more common in patients with pancreatic cancer and patients with Stage IV disease regardless of cancer type. Patients with VTE before initiation of cancer treatment, even asymptomatic distal DVT, had a higher risk of subsequent symptomatic VTE, bleeding, and all-cause death.
Results date posted	2022 Year 09 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 04 Month 28 Day
Baseline Characteristics	In one-year follow-up analysis, 51.4% were male and the average age was 66.7 years. By cancer type, colon cancer 25.7%, lung cancer 24.7%, stomach cancer 19.7%, pancreatic cancer 10.4%, breast cancer 10.3%, and gynecologic cancer 9.1%.Cancer Stage I was 6.1%, IB 4.8%, II 35.3%, III 29.9%, and IV 23.8%.
Participant flow	A total of 10202 patients were enrolled, and 9630 were included in the one-year follow-up analysis.
Adverse events	data not shown
Outcome measures	(1) The baseline prevalence of VTE was 5.9%. (2) The incidence of symptomatic VTE events during the one-year follow-up was 0.5%, and the incidence of bleeding events was 1.4%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 11 Day
Date of IRB	2016 Year 11 Month 24 Day
Anticipated trial start date	2017 Year 03 Month 10 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information	Multicenter Prospective Registry

Management information
Registered date	2016 Year 11 Month 22 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028694