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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2090220415
Enrollment
90
Registered
2019-03-07
Start date
2019-04-01
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

primary hepatic tumor

Interventions

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use:

Sponsors

Takeda Sen
Lead Sponsor
University of Yamanashi, Japanese Red Cross Medical Center, The University of Tokyo, Nihon University, Juntendo University, Teikyo University, National Center for Global Health and Medicine, National Cancer Cente Hospitalr
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: (1) Those who attend the living donor liver transplantation (2) Those with difficulty in specifying or collecting the S specimen

Design outcomes

Primary

MeasureTime frame
Concordance rate of diagnosis by this machine with pathohistological diagnosis on the definitive S specimen

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKaneo Satoh

University of Yamanashi Hospital

ksatoh@yamanashi.ac.jp+81-55-273-9325

Outcome results

None listed

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