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临床试验/JPRN-jRCT1032200145
JPRN-jRCT1032200145已完成未知

Clinical performance test for germline genetic test KMPMJ-G01

Tsugawa Koichiro0 个研究点目标入组 150 人开始时间: 2020年10月12日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
150

研究概览

简要总结

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.

研究设计

研究类型
Other

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Tsugawa Koichiro

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