UMIN-CTR Clinical Trial

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
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Interventions/Control_7
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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
Email	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
Email	yharada@cc.saga-u.ac.jp

Sponsor
Institute	Clinical Research Center, Saga University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030793