Polygene detection primers for predicting risk of distant recurrence of early breast cancer

A technology for detecting primers and multiple genes, which is applied in the determination/inspection of microorganisms, biochemical equipment and methods, DNA/RNA fragments, etc. It can solve the problems that the sensitivity and specificity of the test system have not been effectively verified, and achieve enhanced detection Good sensitivity and primer specificity

Pending Publication Date: 2021-04-13
郑鸿钧
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  • Abstract
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  • Claims
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Problems solved by technology

However, the research and development of the currently available gene expression panels (Oncotype Dx, MammaPrint, EndoPredict) were all carried out in the United States or Europe, and the majority of the included cases were Caucasian, a small number of Africans and a very small number of Asians. The sensitivity and specificity of the test system have not been effectively verified

Method used

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  • Polygene detection primers for predicting risk of distant recurrence of early breast cancer
  • Polygene detection primers for predicting risk of distant recurrence of early breast cancer
  • Polygene detection primers for predicting risk of distant recurrence of early breast cancer

Examples

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Embodiment 1

[0056] A method for predicting the risk of distant recurrence in early breast cancer (Clinical Variable Model 6 (CV6))

[0057] Based on 1010 patients treated in our hospital from 1990 to 2001, a prognostic scoring system for Local-Regional Recurrence (LRR) after mastectomy was established in 2006. This prognostic scoring system has been validated on the basis of 1545 patients treated in 2013 at the same hospital during 2002-2007. Subsequently, patients (n=1649) who did not undergo mastectomy (Post-Mastectomy, PMRT) in these two studies were combined, and a multivariate analysis was performed on the risk of 5-year LRR (see Table 1).

[0058] Table 1 Multivariate analysis of 5-year LRR risk in non-PMRT patients (n=1649)

[0059] Variables Hazard ratio 95%CI Age ≤40 1.9 1.1-3.0 >40 1.0 ER status Negative 1.8 1.1-2.9 Positive 1.0 LN positive 0 1.0 1–3 2.9 1.8-4.7 4–9 6.7 2.0-23 >9 16.4 7.2-37 ...

Embodiment 2

[0068] 1. A method for predicting the risk of distant recurrence of early breast cancer

[0069] S1: FFPE tumor tissue samples collected through standard medical sample collection procedures;

[0070] A total of 168 patients with stage I-III breast cancer (among them, 112 patients in the training group and 56 patients in the test group), excluded patients who received chemotherapy before surgery and distant metastases. FFPE tumor tissues were obtained from patients treated in our hospital between 2005 and 2015.

[0071] S2: Utilize RT-PCR technology to detect the relative expression of the polygene described in claim 2;

[0072] S21: RNA extraction from FFPE tumor tissue

[0073] Each archived FFPE tissue sample was cut into 10 μm thick sections and stored or shipped at 4 °C. According to the instructions of RNeasy FFPE kit (Qiagen, CA, USA), the paraffin was removed, total RNA was extracted from FFPE tissue sections, treated with DNase, and then stored at -80°C for later u...

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Abstract

The invention discloses polygene detection primers for predicting a risk of a distant recurrence of early breast cancer and belongs to the technical field of molecular diagnosis. The polygenes comprise BUB1B, BLM, TPX2, DTX2, PIM1, OBSL1, YWHAB, CLCA2, SF3B5, ESR1 and ERBB2. Primer sequences are shown as SEQ ID NO.1-22. The primers have good specificity, all amplicons generated by a PCR amplification are short, and detection sensitivity of RNA extracted from an FFPE sample can be enhanced. The invention further discloses a method for predicting a risk of a distant recurrence of early breast cancer. The relative expression quantity of the polygenes in the FFPE sample is quantified through SEQ ID NO.1-28, a statistical method of a distant recurrence genetic model is established, the risk of the distant recurrence of the early breast cancer can be predicted, patients with low-risk and high-risk breast cancer are divided, and guidance is provided for treatment of postoperative breast cancer.

Description

technical field [0001] The invention belongs to the technical field of molecular diagnosis, and in particular relates to multigene detection primers for predicting distant recurrence risk of early breast cancer. Background technique [0002] Breast cancer is a disease with high incidence worldwide. Due to the popularization of breast cancer screening, improvement of standard treatment and application of multiple genetic tests to assess prognosis, its mortality rate has been significantly reduced. Clinically, breast cancer is no longer regarded as a single disease, and is divided into different subtypes by gene amplification of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2), Each subtype has different tumor biological characteristics, treatment effects and prognosis, etc. Among them, hormone receptor positive breast cancer patients account for 70%-80%, while the clinical prognosis of hormone receptor positive, HER-2 neg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12N15/11
CPCC12Q1/6886C12Q2600/112C12Q2600/118C12Q2600/158
Inventor 郑鸿钧
Owner 郑鸿钧
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