Multilateral clinical trial for validating the performance of rapid cancer diagnosis assisting machine to the primary hepatic tumor
Phase 3
Completed
- Conditions
- primary hepatic tumor
- Registration Number
- JPRN-jRCT2090220415
- Lead Sponsor
- Takeda Sen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
(1) Those who are diagnosed as primary hepatic tumor by medical doctor
(2) Those who agree with the participation to the clinical trial by one's will
(3) Those over the age of 20 years old of both sex on the time of acquisition of agreement
(4) Those who attend the surgical extirpation of liver
(5) Those who have at least one S specimen in the liver
(6) Those who are able to provide the contrast enhanced CT
Exclusion Criteria
(1) Those who attend the living donor liver transplantation
(2) Those with difficulty in specifying or collecting the S specimen
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance rate of diagnosis by this machine with pathohistological diagnosis on the definitive S specimen
- Secondary Outcome Measures
Name Time Method Concordance rate of diagnosis by this machine with pathohistological diagnosis on the non S specimen judged by the central committee. Sensitivity, specificity, positive and negative predictive value for the machine diagnosis.