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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035432
Receipt No. R000039798
Official scientific title of the study The elucidation of the coagulation and fibrinolysis system in a cancer patients, and search of a biomarker
Date of disclosure of the study information 2019/02/05
Last modified on 2019/01/03

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Basic information
Official scientific title of the study The elucidation of the coagulation and fibrinolysis system in a cancer patients, and search of a biomarker
Title of the study (Brief title) The elucidation of the coagulation and fibrinolysis system in a cancer patients
Region
Japan

Condition
Condition Esophageal cancer, Gynecological cancer, Lung cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarification of detail condition of hypercoagulability and hyperfibrinolytic state in each cancer patients
Basic objectives2 Others
Basic objectives -Others Validation of adverse events other than bleeding in cancer patients. Elucidation of discontinuation rate of cancer therapies after diagnosis of thrombosis. etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Elucidation of detail coagulation-fibrinolysis state before initial treatment for cancers in patients. Clarifying of existence of thrombosis in pre-treatment cancer patients. Revealing rate of thrombotic and bleeding events after starting of thrombolysis therapies.
Key secondary outcomes

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria PS0-2
Cases to which initial cancer treatments are scheduled to be administered
Esophagus cancer
Gynecological cancer
Lung cancer
*We will also consider expanding investigation to gastric cancer, liver cancer, pancreatic cancer and colon cancer, in the future.
Key exclusion criteria Cases with a prognosis of less than 3 months
Cases of pregnancy
Cases judged inappropriate to investigate by attending physicians
Cases with cancer therapy history within the past 6 months
Target sample size 600

Research contact person
Name of lead principal investigator TARO SHIGA
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Department of General Medicine / Onco-Cardiology and Cardiovascular medicine
Address 3-8-31 Ariake, Koto-ward, Tokyo, Japan
TEL 03-3520-0111
Email taro.shiga@jfcr.or.jp

Public contact
Name of contact person CHIKAO YASUDA
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Department of Medical Safety Management
Address 3-8-31 Ariake, Koto-ward, Tokyo, Japan
TEL 03-3520-0111
Homepage URL
Email chikao.yasuda@jfcr.or.jp

Sponsor
Institute The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Department of General Medicine / Onco-Cardiology and Cardiovascular medicine
Institute
Department

Funding Source
Organization JRISTA The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 16 Day
Anticipated trial start date
2019 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information (design)A single center prospective observational study
(Period)Since Feb 2018
(examination)
ultrasonography of leg vein
contrast CT
blood count,ALB, TP, ALP, LDH, AST(GOT), ALT(GPT), T.Bil, AMY, Creatinine, BUN, Na, K, Cl, Ca, etc.
C-reactive protein(CRP), B-type natriuretic peptide(BNP), troponin I
Coagulation and fibrionolysis system:
PT, APTT, Fbg, FDP, D-dimer, TAT, Antithrombin
Plasma thrombomodulin, soluble fibrin monomer, fibrin monomer complex
total PAI-1, t-PA, t-PA/PAI-1 conmlex
coagulation factors(II, V, VIII, IX, XI, XIII), prothrombin fragment 1+2 (F1+F2), Tissue Factor
protein C and S
tumor markers
vWF activity, soluble P-selectin

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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