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Systemic detection method of tumor marker and application thereof

A tumor marker and detection method technology, applied in biological tests, measuring devices, material inspection products, etc., can solve the problems of low specificity, ineffective early diagnosis of tumors, and low sensitivity.

Inactive Publication Date: 2018-02-23
BIOCHAIN BEIJING SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Carcino-embryonic antigen (CEA) is a broad-spectrum tumor marker, in addition to primary colon cancer, breast cancer and lung cancer, pancreatic cancer, bile duct cancer, gastric cancer, esophageal cancer, mucinous adenocarcinoma and urinary system cancer The positive rate of tumors is also increased, it can reflect the existence of a variety of tumors, and it is a good tumor marker for the judgment of curative effect, disease development, monitoring and prognosis estimation of colorectal cancer, breast cancer and lung cancer. It is recognized in the industry that its specificity is not strong, its sensitivity is not high, and its role in the early diagnosis of tumors is not obvious

Method used

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  • Systemic detection method of tumor marker and application thereof
  • Systemic detection method of tumor marker and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0169] Example 1 Combine gene methylation and protein tumor markers

[0170] The combined use of gene methylation and protein tumor markers can increase the sensitivity of detection and improve the success rate of early tumor diagnosis. In a clinical trial of 1031 cases of Septin9 gene methylation kit for detecting colorectal cancer, the hospital laboratory department used the Septin9 gene methylation kit to detect the gene methylation content in the plasma of the subject, and the stool of the hospital laboratory The Fecal Immunochemical Test (FIT) kit detects the hemoglobin in the stool of the subject, or uses the CEA of the hospital laboratory to detect the CEA content in the blood of the subject.

[0171] As shown in Table 1, when the three indicators are detected separately, the sensitivity of Septin9 for detecting tumors is 77%, the specificity is 96%, and the sensitivity for detecting early tumors is 68%, which are better than FIT (70%, 95%). , 58%) and CEA (52%, 85%, 31%) ...

Embodiment 2

[0178] Example 2 Combining two genes to methylate tumor markers

[0179] The combined use of different gene methylation tumor markers can increase the sensitivity of detection and improve the success rate of early tumor diagnosis. In 202 cases of the Septin9+RNF180 gene methylation kit for gastric cancer clinical trials, the hospital laboratory department used the Septin9+RNF180 gene methylation kit to detect the level of gene methylation in the subject's plasma. As shown in Table 2, when the two indicators are analyzed separately, the sensitivity of Septin9 and RNF180 for detecting tumors is 43% and 48%, respectively, which are both below 50%. The results of Septin9 and RNF180 are comprehensively analyzed and combined to detect tumors. The sensitivity is 66%, an increase of 18%, and the specificity remains unchanged. The results suggest that the combined use of different gene methylation tumor markers to improve the overall tumor detection sensitivity (18%) is similar to the c...

Embodiment 3

[0183] Example 3 Systematic testing implementation and combination method

[0184] According to different testing purposes, systematic testing can be combined flexibly. As shown in Table 3, different combinations can be formed, including 1) Combining multi-gene multi-characteristic high-throughput testing and various protein tumor marker testing methods together Form a comprehensive plan; 2) Combine the multi-gene and multi-characteristic high-throughput detection and the detection methods of various protein tumor markers to form a liquid biopsy scheme; 3) The multi-gene and multi-characteristic high-throughput detection of key gene mutations and various Combine the detection methods of protein tumor markers to form a gene mutation combination scheme; 4) Combine the multi-gene and multi-characteristic high-throughput detection methods of key gene methylation and various protein tumor markers detection methods to form gene A Combination scheme of basicization; 5) Combine the dete...

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Abstract

The invention provides a systemic detection method of a tumor marker and application thereof. The method comprises the following steps: 1) providing a sample from a checking object, wherein the checking object is a person; 2) detecting the sample of step 1), wherein in the detection step, whether various protein tumor markers exist or not is determined by utilizing high-throughput nucleic acid sequencing and determination comprising polygene mutation, polygene methylation, a plurality of micro RNAs (Ribonucleic Acid) and the like and utilizing a protein chip. According to the systemic detection method of the tumor marker and the application thereof, the different tumor markers are subjected to systemic detection including DNA (Deoxyribonucleic Acid), RNA, protein and the like, so that thesensitivity of early-stage detection of the tumors is improved.

Description

Technical field [0001] The present invention relates to the detection of disease markers, in particular to a systemic method for detecting tumor markers that combines gene markers and tumor protein markers for in vitro auxiliary diagnosis of diseases. Background technique [0002] Cancer is one of the leading causes of death in the world: In 2004, the global cancer death toll reached 7.4 million (approximately 13% of all deaths). The global cancer death toll will continue to increase. In 2030, the death toll is expected to reach 12 million. About 84 million people died of cancer worldwide from 2005 to 2015. The main types of cancer that cause total cancer mortality each year are: lung cancer (1.3 million), gastric cancer (803,000), colon cancer (639,000), liver cancer ( 610,000) and breast cancer (519,000). In 2015, there were 1.7 million new cancer cases in the United States. In 2015, it is estimated that there are about 4,291,600 new cancer cases in China each year, and 2,814...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/57484G01N33/6893
Inventor 韩晓亮王建铭徐海马竣宋乐乐周光朋
Owner BIOCHAIN BEIJING SCI & TECH
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