Clinical performance test of KMPMJ-G01

JRCT ID: jRCT1032200145

Registered date:12/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast or ovarian cancer
• Date of first enrollment: 21/10/2020
• Target sample size: 138
• Study type: Other
• Intervention(s): none

Outcome(s)

• Primary Outcome: The percentage of agreement between the results of the control test and the analysis of this product
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tsugawa Koichiro
• Secondary Sponsor: Takama Masaaki,Konica Minolta Precision Medicine Japan, Inc.
• Secondary ID(s): Nil known