UMIN-CTR Clinical Trial

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

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	Obstetrics and Gynecology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Medical Science Department
Daiichi Sankyo Company, Limited.

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2017

Year

02

Month

10

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5988100/

Publication of results

Published

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

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 related information

Multicenter Prospective Registry

Registered date

2016

Year

11

Month

22

Day

Last modified on

2022

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028694