UMIN-CTR Clinical Trial

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
Email	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
Email	qttsp974@gmail.com

Sponsor
Institute	Japanese Red Cross Okayama Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055709