CN-122017241-A - Molecular marker for detecting and differential diagnosing breast cancer and benign breast tumor and application thereof

Abstract

The invention relates to a molecular marker for detecting and differential diagnosis of breast cancer and benign breast tumor and application thereof, relates to the field of detection of disease diagnosis markers, and aims to solve the problem of lack of molecular markers for differential diagnosis of breast cancer and benign breast tumor at present. The invention discovers that the content level of Cyst C in the blood of a breast cancer patient is obviously lower than that of a benign breast tumor patient, and the content level of beta 2-m in the blood of the breast cancer patient is obviously lower than that of a benign breast tumor patient, and the specificity and the sensitivity of independently detecting the levels of Cyst C and beta 2-m in the blood for the differential diagnosis of breast cancer and benign breast cancer are not high, but the combination of Cyst C and beta 2-m has better specificity and sensitivity when the combination is applied to the differential diagnosis of breast cancer and benign breast cancer.

Inventors

• LI KESHENG
• CHEN XIA
• ZENG CHAONING
• DU HUIFEN

Assignees

• 兰州雅华生物技术有限公司

Dates

Publication Date

20260512

Application Date

20241105

Claims (5)

1. 1. A molecular marker for detecting and distinguishing and diagnosing breast cancer and benign tumor of breast is characterized by consisting of Cyst C and beta 2-M proteins.
2. 2. The use of the molecular marker for the differential diagnosis of detection of breast cancer and benign breast tumor according to claim 1 in the establishment of a detection method for the differential diagnosis of breast cancer and benign breast tumor.
3. 3. The use according to claim 2, wherein said establishing a differential diagnosis of breast cancer and benign breast tumor is performed by measuring the level of said molecular marker in the blood of a breast cancer patient, and comparing it with said molecular marker in the blood of a benign breast tumor patient.
4. 4. The use according to claim 3, characterized in that the level of said molecular marker in the blood of a breast cancer patient is detected and compared with the level of said molecular marker in the blood of a benign breast tumor patient, said comparison being such that the level of the molecular marker Cyst C in the blood of a breast cancer patient is lower than the level of said molecular marker Cyst C in the blood of a benign breast tumor patient, and the level of the molecular marker β2-M in the blood of a breast cancer patient is higher than the level of said molecular marker β2-M in the blood of a benign breast tumor patient.
5. 5. The kit for detecting the molecular markers for the differential diagnosis of breast cancer and benign breast tumor according to claim 1 is characterized by comprising a colloidal gold labeled Cyst C antibody, a nitrocellulose membrane coated by the Cyst C antibody, a sample diluent, a colloidal gold labeled beta 2-M antibody, a nitrocellulose membrane coated by the beta 2-M antibody and the sample diluent, and assembling the Cyst C and beta 2-M kits according to an immunochromatography detection kit.

Description

Molecular marker for detecting and differential diagnosing breast cancer and benign breast tumor and application thereof Technical Field The invention belongs to the field of disease diagnosis, and in particular relates to a method for distinguishing whether an individual belongs to breast cancer or not by utilizing a molecular marker and distinguishing diagnosis with benign breast tumor. Background Breast tumors account for approximately 2/3 of breast disease, with a proportion of approximately 1/3 of breast benign tumors, breast malignant tumors and other diseases of the breast, each of which is about 1/3, wherein breast Cancer (BCa) is the leading cause of Cancer-related death in females [ Bray F, et al ca Cancer J clin.2018], early detection of breast Cancer has a good long-term prognosis, with a total 5-year survival rate of greater than 90% [ Bray F, et al ca Cancer J clin.2018]. However, advanced breast Cancer has a poor prognosis, with a total 5-year survival approaching 20% [ brain F, et al ca Cancer J clin.2018]. Thus, early diagnosis of BCa may lead to better therapeutic responses and more favorable clinical results [ brain F, et al ca Cancer J clin.2018], on the other hand, timely diagnosis may significantly reduce the cost and complexity of clinical treatment, which has been consensus that the goal is to increase the clinical stages of disease diagnosis [ brain F, et al ca Cancer J clin.2018 Sun L, et al PLoS one.2018 ]. At present, the clinical breast tumor examination comprises the visual inspection and palpation of clinicians, the color ultrasound and molybdenum target examination of the breast and the like. Breast ultrasound examination is primarily classified by BI-RADS (Breast Imaging Reporting DATA SYSTEM), breast imaging reporting system) to determine malignant and benign tumors. The BI-RADS classification includes stages 0-6, with higher stages generally representing higher malignancy. If the ratio is 0, the growth speed of the breast tumor is generally slow, the shape is regular, the surrounding tissues are not obviously infiltrated, and the surrounding blood vessels are not very abundant, so that the breast tumor is usually benign. If the ratio is 6, it is usually indicated that the breast tumor belongs to malignant tumor, the peripheral blood vessels are rich, the surface is usually not smooth, and the peripheral tissues are infiltrated, metastasis occurs and the like. Molybdenum target examination, also called mammography examination, is the simplest noninvasive imaging detection means for diagnosing breast diseases, and the left image can be used for comparing the changes of breast glandular tissues at different time periods, so that breast tumors which cannot be touched by a clinician can be detected. Whether it is a clinical examination or an ultrasound and molybdenum target examination, the most accurate method of distinguishing breast tumors is a pathological examination, which generally employs a mammary gland puncture pathological examination. Although the above examination greatly improves the early diagnosis rate of clinical breast cancer, the clinical diagnosis results of benign breast tumor and breast cancer are different due to the influence of subjective factors such as personal business level of clinical medical staff, and more scientific and reliable laboratory examination indexes are needed. Thus, one of the important directions in current breast Cancer research is the discovery of new molecular markers that can help clinicians detect early BCa patients and provide accurate estimates of prognosis and predictions of response to clinical therapies [ Nicolini A, et al semin Cancer biol 2018. Leto G, et al Clin Exp Pharmacol physiol 2019]. However, the complex heterogeneity of breast cancer makes the discovery of highly specific, sensitive biomolecular markers more difficult. In recent decades, the use of advanced techniques such as high-throughput genealogy, transcriptomics, quantitative proteomics, metabolomics, single-cell sequencing, etc., has greatly facilitated a further understanding of the molecular mechanisms driving tumor cell growth, invasion and metastasis. Numerous experimental and clinical findings also provide reliable scientific evidence that lysosomal cysteine proteases are up-regulated in breast cancer and that their expression levels are significantly correlated with malignant progression of breast cancer. The findings also show that altered regulation of a specific endogenous inhibitor of the breast cancer lysosomal cysteine protease (i.e. cystatin) is one of the possible causes of elevated breast cancer cysteine protease levels. Among cysteine protease inhibitors, cysteine protease inhibitor C (Cyst C) is the most potent inhibitor of cysteine cathepsins, and new studies have demonstrated that Cyst C may be a new potential therapeutic target for breast cancer, and Cyst C may also be a potential neogenesis marker for the prognosis of BCa pat