UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048891 |
|---|---|
| Receipt number | R000055709 |
| Scientific Title | Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2022/09/08 18:42:15 |
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Basic information
Public title
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer
Acronym
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer
Scientific Title
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer
Scientific Title:Acronym
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this prospective study is to identify the incidence of cancer-associated thrombosis in patients with newly diagnosed biliary tract cancer
Basic objectives2
Others
Basic objectives -Others
the risk factor of cancer-associated thrombosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of cancer-associated thrombosis during the observation period
Key secondary outcomes
1. the risk factor of cancer-associated thrombosis
2. thrombosis improvement rate and complication rate by anticoagulant therapy for cancer-associated thrombosis
3. overall survival
4. progression-free survival
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. informed consent in writing given freely.
2. 20 years old or older at written informed consent.
3. patients with newly diagnosed biliary tract cancer.
4. patients with a definitive diagnosis of biliary tract cancer pathologically
Key exclusion criteria
1. patients with serious complications in other organs.
2. patients with postoperative recurrence of biliary tract cancer.
3. patients who are inappropriate as a subject of the study judged by the treating physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Akimoto |
Organization
Japanese Red Cross Okayama Hospital
Division name
Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe Okayama kita Okayama,Japan
TEL
086-222-8811
qttsp974@gmail.com
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Akimoto |
Organization
Japanese Red Cross Okayama Hospital
Division name
Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe Okayama kita Okayama,Japan
TEL
086-222-8811
Homepage URL
qttsp974@gmail.com
Sponsor or person
Institute
Japanese Red Cross Okayama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Japanese Red Cross Okayama Hospital
Address
2-1-1 Aoe Okayama kita Okayama,Japan
Tel
086-222-8811
qttsp974@gmail.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 09 | 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
| 2022 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055709
