UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044564 |
|---|---|
| Receipt number | R000050504 |
| Scientific Title | Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed pancreatic cancer |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2025/09/01 20:33:03 |
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Basic information
Public title
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed pancreatic cancer
Acronym
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed pancreatic cancer
Scientific Title
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed pancreatic cancer
Scientific Title:Acronym
Prospective observational study of cancer-associated thrombosis in patients with newly diagnosed pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic 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 pancreatic 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 incidence of intracardiac thrombus on transesophageal echocardiography at the time of the endoscopic ultrasound-guided fine needle aspiration
2.the risk factor of cancer-associated thrombosis
3.thrombosis improvement rate and complication rate by anticoagulant therapy for cancer-associated thrombosis
4.over all survival
5.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 pancreatic cancer.
4.patients with a definitive diagnosis of pancreatic cancer pathologically
Key exclusion criteria
1.patients with serious complications in other organs.
2.patients with postoperative recurrence of pancreatic cancer.
3.patients who are inappropriate as a subject of the study judged by the treating physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Oki |
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
p023eb@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Oki |
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
p023eb@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
oka-rcgh@okayama-med.jrc.or.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
| 2021 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000050504
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000050504
Number of participants that the trial has enrolled
54
Results
Pancreatic cancer frequently presented with concomitant VTE. All cases of VTE were asymptomatic, and D-dimer levels may be useful for diagnosis.
Results date posted
| 2025 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age 72 years range (47-84), male/female 30/24 cases, stage 4 25cases
Participant flow
This study included 54 patients diagnosed with pancreatic cancer at our hospital between June 2021 and December 2022 who met the inclusion criteria.
Adverse events
none.
Outcome measures
At initial visit, DVT was identified in 6 of 54 cases (11.1%), but no PE was detected. All DVTs were asymptomatic, with 1 case of proximal type and 5 cases of distal type. Risk factors identified in univariate analysis showed Hb, D-dimer, and CEA. In multivariate analysis, D-dimer was an independent VTE-associated factor (OR 1.23). No VTE was observed in cases with D-dimer levels below the reference value. Regarding cumulative VTE incidence, 8 new cases occurred within 6 months after pancreatic cancer diagnosis, and 10 cases occurred during the entire follow-up period. All cases were distal type DVT and asymptomatic, diagnosed at a median of 71 days after pancreatic cancer diagnosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | 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
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | 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=R000050504
