Establishment of composition for early diagnosis of ovarian cancer

A technology for ovarian cancer and in vitro diagnosis, which is applied in the determination/inspection of microorganisms, biochemical equipment and methods, instruments, etc., can solve the problems of low tumor burden, no mutation detection or missed detection, and low ctDNA mutation abundance, etc. To achieve the effect of improving specificity and sensitivity

Active Publication Date: 2021-11-30
上海允晟医学检验所有限公司
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Problems solved by technology

However, patients with early-stage ovarian cancer have a lower tumor burden, less cfDNA released into the blood, and a lower mutation abundance in ctDNA, requiring extremely sensitive techniques to detect
Although ctDNA-NGS sequencing technology is constantly improving, patients with early ovarian tumors still have no mutation detection or missed detection

Method used

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  • Establishment of composition for early diagnosis of ovarian cancer
  • Establishment of composition for early diagnosis of ovarian cancer
  • Establishment of composition for early diagnosis of ovarian cancer

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preparation example Construction

[0097] The preparation of the capture antibody can be obtained by linking the monoclonal antibody against the target biomarker to the magnetic particles under appropriate reaction conditions in the presence of a coupling solution. Further, the detection antibody can be a monoclonal antibody labeled with alkaline phosphatase, a monoclonal antibody labeled with alkaline phosphatase, and combinations thereof.

[0098] As an embodiment of the protein chip of the present invention, the capture antibody is immobilized on microspheres carrying specific detectable signals (molecules) to prepare a liquid-phase protein chip, and the principle of detection by using the liquid-phase protein chip is: A single microsphere is passed through a detection channel, and both lasers are used to simultaneously detect the microsphere identification signal and the detectable signal on the microsphere. One type of laser excites the microsphere identification signals on the microspheres. According to t...

Embodiment 1

[0153] 1. Blood Sample Collection

[0154] Venous blood was collected using free DNA blood collection tubes (LBgard blood collection tubes, Biomatirca, USA), and samples were sent to Shanghai Yunsheng Medical Laboratory (Shanghai, China) at room temperature (4°C-37)°C for plasma and white blood blood cell, WBC) separation. All subjects underwent 10 mL whole blood sample collection. Plasma and peripheral blood samples were drawn before anesthesia on the day of surgery. The plasma of healthy volunteers in the biological sample bank is stored at -80°C, not less than 3mL, and the storage time is within 2 years, and it is transported to Shanghai Yunsheng Medical Laboratory by dry ice.

[0155] 2. Extraction of cfDNA and genomic DNA

[0156] Peripheral blood (10 mL for each freshly collected sample, 3 mL for biobank samples) was centrifuged at 4°C, 1600 g, for 10 minutes. Plasma (upper yellow layer) and white blood cells (middle layer) were collected, and then the upper layer of...

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Abstract

The invention relates to the field of tumor diagnosis, and discloses establishment of a composition for early diagnosis of ovarian cancer, ovarian cancer can be predicted, diagnosed and/or prognostically evaluated by measuring cfDNA content, cfDNA TP53 mutation abundance and CA125 protein expression level, the sensitivity, specificity and accuracy of the composition reach 91.11%, 94.34% and 93.38%, and the detection rate of early ovarian cancer reaches 78.9%. By adopting the marker combination and the model scoring method disclosed by the invention, 71.05% of patients can be detected in CA125 negative ovarian cancer patients, 74% of subjects can be correctly judged in CA125 positive non-tumor people, and the problems of CA125 leak detection and error detection can be well solved. According to the invention, an effective early ovarian cancer diagnosis or screening marker can be provided clinically, and the prediction accuracy and the detection rate of the early ovarian cancer can be improved.

Description

technical field [0001] The invention relates to the field of tumor diagnosis or screening, and relates to the establishment of a composition for early diagnosis of ovarian cancer, in particular to a combination of ovarian cancer biological standards and its application, kit and evaluation model. Background technique [0002] The annual incidence rate of ovarian cancer ranks third in female reproductive system tumors, showing an increasing trend year by year, after cervical cancer and uterine malignant tumors, and its mortality rate ranks first in gynecological tumors. It is one of the malignant tumors that seriously threaten women's health. The 5-year survival rate of patients with stage I ovarian cancer can exceed 90%, while the 5-year survival rate of advanced ovarian cancer is <20%. The ovary is deep in the pelvic cavity. When the ovarian lesion is in the early stage, there are often no specific clinical symptoms, and when the symptoms appear, 70% of the patients are a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886G01N33/574G16H50/30
CPCC12Q1/6886G01N33/57488G01N33/57449G16H50/30C12Q2600/106C12Q2600/118C12Q2600/156C12Q2600/158C12Q2600/178
Inventor 程晓东王芬芬李阳陈晓静陆伶佳
Owner 上海允晟医学检验所有限公司
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