UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026826
Receipt No. 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 2019/04/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Enrolling by invitation
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
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 09 Month 30 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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.