Clinical performance test of KMPMJ-G01

Not Applicable

• Conditions: Breast or ovarian cancer

• Registration Number: JPRN-jRCT1032200145
• Lead Sponsor: Tsugawa Koichiro

Brief Summary

In this study, concordance between our evaluated method (KMPMJ-G01) and reference method was evaluated. Using the samples judged by each mehod, concordance date was calculated. Finally, its 100 percent from total 139 data set and it suggested our system had statistically enough wquivalence to the reference method.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Study Completion: 2021-07-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The patient must meet all of the following selection criteria (1) to (3)
(1) The person has the consent ability and is over 20 years old (regardless of gender)
(2) Patients diagnosed with breast or ovarian cancer who have a control test result before enrollment in this study
(3) Patients who have obtained informed consent for the provision of control test results and / or the provision of the specimens and the use of such specimens

Exclusion Criteria

In the case of biological samples, patients who meet any of the following at the time of blood collection are excluded
(1) Patients with a history of or having blood cancer
(2) Patients who have a history of or have a solid tumor other than breast and ovarian cancer
(3) Patients with a history of blood transfusion within 4 weeks
(4) Patients who received allogeneic hematopoietic stem cell transplantation
(5) Patients with a history of hematopoietic tumor
(6) Other patients who are judged inappropriate by the investigator or researcher

Study & Design

• Study Type: Other
• Study Design: Not specified