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Prospective study for predictive biomarkers and modified risk scoring model for venous thromboembolism in Japanese patients with unresectable or metastatic cancer.

Prospective study for predictive biomarkers and modified risk scoring model for venous thromboembolism in Japanese patients with unresectable or metastatic cancer. - PRiDICT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000026826
Enrollment
240
Registered
2017-04-01
Start date
2017-04-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer, esophageal cancer, gastric cancer, biliary tract cancer, pancreatic cancer, colorectal cancer

Interventions

None listed

Sponsors

Clinical Research Center, Saga University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Objectively confirmed symptomatic or asymptomatic VTE

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYohei Harada

Saga University Hospital Division of Hematology and Oncology

yharada@cc.saga-u.ac.jp0952-34-2366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026