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Marker, primer probe and kit for early screening and diagnosis of endometrial cancer

An endometrial cancer and marker technology, which is applied in the determination/inspection of microorganisms, biochemical equipment and methods, DNA/RNA fragments, etc., can solve the problems of low detection sensitivity, invasiveness of endometrial cells, etc. High sensitivity, high accuracy, and the effect of reducing errors

Active Publication Date: 2021-12-07
BEIJING ORIGIN-POLY BIO-TEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The clinical detection of endometrial cancer mainly adopts transvaginal ultrasonography, or cytology detection based on endometrial sampler and diagnostic curettage, etc. On the one hand, the detection sensitivity is low, and on the other hand, directly collecting endometrial cells has a certain degree of invasion. sex

Method used

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  • Marker, primer probe and kit for early screening and diagnosis of endometrial cancer
  • Marker, primer probe and kit for early screening and diagnosis of endometrial cancer
  • Marker, primer probe and kit for early screening and diagnosis of endometrial cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Detection kit for detection of methylation of endometrial cancer-related genes CDO1, CELF4, HAND2 and HS3ST2.

[0076] The specific nucleotide sequences of the primers and probes used are shown in the table below:

[0077]

[0078]

[0079] Note: F represents the forward detection primer, R represents the reverse detection primer, and FP represents the detection probe. In this table, the probe sequences shown have been labeled with fluorophores and quenchers.

[0080] The kit components without sample pretreatment reagents are as follows:

[0081]

[0082]

[0083] Select 60 cases of endometrial cancer samples with known clear pathological information: 15 cases identified as endometrioid carcinoma, 15 cases of endometrial mucinous carcinoma, 15 cases of endometrial serous carcinoma, 15 cases of endometrial clear Cell carcinoma; 40 cases were benign samples of endometrium. The above samples were obtained from the retained samples of cervical exfoliated cel...

Embodiment 2

[0137] Other components in the kit are the same as in Example 1. In Example 1, a small number of single-center samples were tested, and then nearly 1,000 samples were collected from multiple centers for testing. Central Hospital, including 450 samples of endometrial cancer and 650 samples of benign endometrium, a total of 1100 samples.

[0138] Compared with histopathological pathological results, the combined ROC curve area obtained by using this methylation detection kit is 0.98, the overall specificity is 98.5% (640 / 650), and the detection sensitivity of endometrial cancer is 98.9%% (445 / 650). 450).

[0139] The kit in the present invention has been verified by a small number of samples to research on a large number of samples, all of which prove that DNA methylation has high accuracy for early detection of endometrial cancer, and can be detected by exfoliated cells of the cervix. The invention uses a special primer probe design method and a sample pretreatment kit indepe...

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Abstract

The invention discloses a marker, a primer probe and a kit for early screening and diagnosis of endometrial cancer. The marker is partially methylated regions in four genes of CDO1, CELF4, HAND2 and HS3ST2, and detection primers and the probes are designed for the methylated regions and are both of snap ring structures. The kit comprises the primer and the probe. According to the marker, the primer probe and the kit for early screening and diagnosis of the endometrial cancer, the methylated regions are screened and combined to determine the most suitable methylation position for combined diagnosis, so that the sensitivity and specificity of early endometrial cancer detection can be remarkably improved. The kit is particularly suitable for early screening and diagnosis of the endometrial cancer by taking cervical exfoliated cells as a sample, can detect the endometrial cancer even if the concentration of a DNA template is low, has the advantages of noninvasive sampling, high detection speed, higher sensitivity and specificity and the like, can ensure the accuracy of a result, therefore, the purposes of early discovery, early diagnosis and early treatment of the endometrial cancer can be achieved.

Description

technical field [0001] The present invention relates to the technical field of nucleic acid in vitro diagnosis, in particular to the application of specific gene methylation markers to early screening and detection of endometrial cancer, specifically a marker, primer and reagent for early screening and diagnosis of endometrial cancer box. Background technique [0002] Endometrial cancer is an epithelial malignant tumor that occurs in the endometrium. The high incidence age is 50-60 years old, and it is more common in postmenopausal women. In recent years, it has a younger trend. According to the latest global cancer data report, the number of new cases of endometrial cancer in women worldwide will reach 420,000 in 2020, ranking sixth in the incidence of malignant tumors in women worldwide. In 2020, the number of new cases of endometrial cancer in Chinese women will be 80,000, ranking ninth in the incidence of malignant tumors in Chinese women. Endometrial cancer is the fou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12Q1/6858C12N15/11
CPCC12Q1/6886C12Q1/6858C12Q2600/154C12Q2600/166C12Q2523/125C12Q2531/113C12Q2545/101C12Q2563/107
Inventor 熊驷骏
Owner BEIJING ORIGIN-POLY BIO-TEC CO LTD
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