NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00415

Registered date:07/03/2019

Multilateral clinical trial for validating the performance of rapid cancer diagnosis assisting machine to the primary hepatic tumor

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedprimary hepatic tumor
Date of first enrollment01/04/2019
Target sample size90
Countries of recruitmentJapan
Study typeOBSERVATIONAL
Intervention(s)

Outcome(s)

Primary OutcomeConcordance rate of diagnosis by this machine with pathohistological diagnosis on the definitive S specimen. Timepoint:When all the specimens are processed for mass spectrometry and pathohistological diagnosis's completed.
Secondary OutcomeConcordance 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. . Timepoint: When all the specimens are processed for mass spectrometry and pathohistological diagnosis.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include 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
Exclude criteria(1) Those who attend the living donor liver transplantation (2) Those with difficulty in specifying or collecting the S specimen

Related Information

Contact

public contact
Name Kaneo Satoh
Address Clinical Trial Management Office,1110 Shimokato Chuo-City Yamanashi
Telephone +81-55-273-9325
E-mail ksatoh@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital
scientific contact
Name Takeda Sen
Address School of Medicine, Department of Anatomy and Cell Biology,Shimo-Kateau 1110, Chuo, Yamanashi
Telephone +81-55-273-9471
E-mail
Affiliation University of Yamanashi