UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035432 |
|---|---|
| Receipt number | R000039798 |
| Scientific Title | 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 | 2023/01/13 14:11:12 |
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Basic information
Public title
The elucidation of the coagulation and fibrinolysis system in a cancer patients, and search of a biomarker
Acronym
The elucidation of the coagulation and fibrinolysis system in a cancer patients
Scientific Title
The elucidation of the coagulation and fibrinolysis system in a cancer patients, and search of a biomarker
Scientific Title:Acronym
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 |
| Obstetrics 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
1) 18 years of age or older
2) PS0-2: Patients must be at a pathological level that allows them to receive various treatments for cancer and anticoagulation therapy.
3) Histologically or cytologically diagnosed cancer or expected to be diagnosed within the next 3 months.
4) Cases of VTE that occurred before, during, or after cancer treatment and cases scheduled for various cancer-related treatments (as normal controls)
5) Cases with the following cancers for which written consent for this study has been obtained
Lung cancer, stomach cancer, liver cancer, bile duct cancer, gall bladder cancer, pancreatic cancer, colorectal cancer, gynecological cancer, urological cancer, sarcoma, breast cancer, lymphoma
6) To capture the characteristics of cancer-related VTE, it is preferable before anticoagulation is administered. However, in some cases, early initiation of treatment with anticoagulation may be desirable depending on the VTE diagnosis, so approval should be granted after specifying the medication status.
Key exclusion criteria
Cases with a prognosis of less than 3 months
Cases of pregnancy
Cases judged inappropriate to investigate by attending physicians
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | CHIKAO |
| Middle name | |
| Last name | YASUDA |
Organization
Hoshigaoka Medical Center
Division name
Department of Vascular Surgery
Zip code
573-8511
Address
4-8-1 Hosigaoka, Hirakata, Osaka, Japan
TEL
072-840-2641
chikao-knk@umin.ac.jp
Public contact
Name of contact person
| 1st name | CHIKAO |
| Middle name | |
| Last name | YASUDA |
Organization
Hoshigaoka Medical Center
Division name
Department of Vascular Surgery
Zip code
573-8511
Address
4-8-1 Hosigaoka, Hirakata, Osaka, Japan
TEL
072-840-2641
Homepage URL
chikao-knk@umin.ac.jp
Sponsor or person
Institute
Hoshigaoka Medical Cennter
Institute
Department
Personal name
Chikao Yasuda
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)
IRB Contact (For public release)
Organization
Hoshigaoka Medical Center
Address
4-8-1 Hosigaoka, Hirakata, Osaka, Japan
Tel
072-840-2641
chikao-knk@umin.ac.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(design)Multi 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
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039798
