UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026826 |
|---|---|
| Receipt number | R000030793 |
| Scientific Title | Prospective study for predictive biomarkers and modified risk scoring model for venous thromboembolism in Japanese patients with unresectable or metastatic cancer. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/09/14 09:26:32 |
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Basic information
Public title
Prospective study for predictive biomarkers and modified risk scoring model for venous thromboembolism in Japanese patients with unresectable or metastatic cancer.
Acronym
PRiDICT study
Scientific Title
Prospective study for predictive biomarkers and modified risk scoring model for venous thromboembolism in Japanese patients with unresectable or metastatic cancer.
Scientific Title:Acronym
PRiDICT study
Region
| Japan |
Condition
Condition
lung cancer, esophageal cancer, gastric cancer, biliary tract cancer, pancreatic cancer, colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective study is to identify predictive factors for venous thromboembolism (VTE) and open up possibilities for early detection and prevention of VTE.
Basic objectives2
Others
Basic objectives -Others
The study is to examine the association between blood biomarkers or existing risk score models (eg, Khorana risk score and Vienna CATS risk score) and VTE, and modify to suit Japanese cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Objectively confirmed symptomatic or asymptomatic VTE
Key secondary outcomes
Khorana risk score, Vienna CATS risk score, final values of risk score, final values of biomarkers, amount of change in risk score, amount of change in biomarkers, rate of change in risk score, rate of change in biomarkers, all values of risk score, all values of biomarkers
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. 20 years old or older at written informed consent.
2. Patients have a confirmed diagnosis of cancer and the primary site of cancer is following: lung, pancreas, biliary tract, stomach, esophagus, colorectum (both initial and/or recurrence). Except active double cancer (synchronous double cancer) patients but patients with intramucosal cancer can be enrolled.
3. Stage III to IV and unresectable
4. Planned to undergo chemotherapy (including molecularly-targeted drugs and immune checkpoint inhibitors).
5. Expected survival after enrollment must be >=3 months.
6. Planned to undergo contrast-enhanced thorax and abdomen CT before the cancer treatment or carried out it within 2 months. Planned to undergo contrast-enhanced thorax and abdomen CT for the evaluation of cancer status after starting cancer treatment.
7. Informed consent in writing given freely.
Key exclusion criteria
1. Patients have history of VTE in the past.
2. Patients have recently received radiotherapy except for palliative radiation therapy, chemotherapy and surgery except for minor surgery within the last 4 weeks.
3. Patients using anticoagulant drugs (warfarin, heparin and Direct oral anticoagulants) consistently.
4. Patients have serious renal disease: creatinine clearance<30ml/min, or hypersensitivity to CT contrast media.
5. Patients with active infections.
6. Pregnant or possibly pregnant women.
7. Patients with lower limb amputation.
8. Patients who are inappropriate as a subject of the study judged by the treating physicians or investigator.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Aragane |
Organization
Saga University Hospital
Division name
Division of Respiratory Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, 849-8501
TEL
0952-34-2369
sueokan@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Harada |
Organization
Saga University Hospital
Division name
Division of Hematology and Oncology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, 849-8501
TEL
0952-34-2366
Homepage URL
yharada@cc.saga-u.ac.jp
Sponsor or person
Institute
Clinical Research Center, Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga, 849-8501
Tel
0952-34-3909
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学医学部（佐賀県）Faculty of Medicine, Saga Univ.
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. Investigation whether longitudinal analysis of blood biomarkers or risk score is more useful than single-point analysis.
2. Investigation whether soluble fibrin and plasminogen-activator inhibitor 1 which are blood biomarkers of coagulation and fibrinolysis is useful to predict VTE in cancer patients.
Management information
Registered date
| 2017 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030793
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