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Product for malignant tumor related screening and assessing, and application and method thereof

A technology for malignant tumors and products, applied in the fields of biotechnology and medicine, it can solve the problems of difficult comprehensive consideration of detection, low sensitivity and specificity, and a positive rate of less than 70%.

Active Publication Date: 2016-01-27
SHANGHAI ZHIXIAN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some serum tumor markers currently available, including alpha-fetoprotein (AFP), cancer antigen 125 (CA125), carcinoembryonic antigen (CEA), cancer antigen 15-3 (CA15-3) and prostate-specific antigen (PSA ), etc., their sensitivity and specificity are generally not high
Even the most sensitive AFP has a diagnostic positive rate of less than 70%
On the other hand, these tumor markers are basically aimed at a certain type or type of tumor, and it is difficult to fully consider them when used for detection.

Method used

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  • Product for malignant tumor related screening and assessing, and application and method thereof
  • Product for malignant tumor related screening and assessing, and application and method thereof
  • Product for malignant tumor related screening and assessing, and application and method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0322] Example 1.Gal ratio is used for the screening / screening of malignant tumors

[0323] The degree of IgG galactosylation in control serum samples (n=924) and malignant tumor patient serum samples (n=1737) was determined using the materials and methods described above. The test results are as follows:

[0324] 1. By observing the MS spectra of a total of 2661 serum IgGN-sugar chains, it can be found that there are significant differences in the Gal ratio between malignant tumor patients and controls. Representative spectra such as figure 1 shown.

[0325] 2. The Gal ratio of 2661 samples was compared, and the receiver operating characteristic curve (receiver operating characteristic curve, ROC curve) analysis was carried out at the same time. The results show that: using the Gal ratio as the tumor screening index, the AUC is 0.9385 (95% confidence interval: 0.9125-0.9608), and the corresponding specificity is as high as 88% when the control sensitivity is 90% (see F...

Embodiment 2

[0342] Example 2. Gal ratio for distinguishing ovarian cancer patients from controls (healthy and benign disease)

[0343] Samples obtained from ovarian cancer patients (n=235) and controls (n=924) obtained AUC=0.9486 (95% confidence interval: 0.9329, 0.9644), see Figure 2B .

[0344] The mean Gal ratio of ovarian cancer patients was significantly different from that of control samples (t test, p<0.0001). (See Table 3A).

[0345] The above analysis confirmed that the serum IgG galactosylation index of the present invention can effectively screen and distinguish ovarian cancer patients and controls with high sensitivity and specificity.

Embodiment 3

[0346] Example 3. Gal Ratio Used to Distinguish Lung Cancer Patients from Controls

[0347] AUC=0.9578 (95% confidence interval: 0.9433, 0.9724) obtained from samples obtained from lung cancer patients (n=206) and controls (healthy persons and benign diseases) (n=924), see Figure 2C .

[0348] The mean Gal ratio of lung cancer patients was significantly different from that of control samples (t test, p<0.0001) (see Table 3A).

[0349] The above analysis proves that the serum IgG galactosylation index of the present invention can effectively screen and distinguish lung cancer patients from controls with high sensitivity and specificity.

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Abstract

The invention provides a product for malignant tumor related screening and assessing, and an application and a method thereof, and concretely relates to a product for carrying out screening, early stage diagnosis, prognosis assessment, risk assessment, condition monitoring and / or curative effect assessment on malignant tumors through detecting the change of double antenna complex N-linked sugar chain end galactose on the surface of immunoglobulin G in blood, and an application and a method thereof.

Description

technical field [0001] The invention belongs to the fields of biotechnology and medicine. Specifically, the present invention relates to a method for screening, early diagnosis, prognosis evaluation, risk assessment, condition monitoring and / or Products and methods for efficacy assessment. Background technique [0002] Tumor is one of the diseases that seriously threaten human health in the world today, and it has the characteristics of long-term and multi-stage. When the patient has symptoms and goes to the hospital for treatment, the tumor has often developed to the middle and late stage, which brings great difficulties to clinical treatment. However, the mortality rate of advanced tumors is very high, and the five-year survival rate is often only 20%. If tumors can be detected at an early stage, monitored for development and changes, and treated in time, the five-year survival rate of tumors can reach 80%. At present, the medical community generally believes that seco...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/68G01N33/6848G01N33/6851G01N33/6854
Inventor 任士芳顾建新张泽建周蕾孙琳琳
Owner SHANGHAI ZHIXIAN BIOLOGICAL TECH CO LTD
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