Gastric cancer prognosis biomarker and application thereof

A biomarker and prognostic technology, applied in biological testing, biomaterial analysis, instruments, etc., can solve the problems of single-cell phenotype monitoring that cannot CTC, cannot achieve accurate monitoring, etc., and achieve a minimally invasive, safe and The effect of improving the specimen acquisition process and predicting overall survival

Active Publication Date: 2022-05-03
BEIJING CANCER HOSPITAL PEKING UNIV CANCER HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cell Search ® At present, CTC detection technology can only detect the number of CTCs in the peripheral blood of patients with malignant tumors, and cannot further monitor the single-cell phenotype of CTCs
Further development of SE-iFISH ® Although technology can monitor CTC karyotype and tumor markers based on CTC counting, it is still unable to accurately monitor the single-cell CLDN18.2 target of CTC in patients with gastric cancer

Method used

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  • Gastric cancer prognosis biomarker and application thereof
  • Gastric cancer prognosis biomarker and application thereof
  • Gastric cancer prognosis biomarker and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 Separation and identification method of patient sample

[0025] A total of 92 patients with advanced gastric cancer who were treated in the Department of Gastroenterology and Oncology of Peking University from November 2017 to May 2021 were prospectively enrolled. Among them, 52 were male patients and 40 were female patients. 69 patients were ≤60 years old and 23 patients were >60 years old. All patients were diagnosed with advanced gastric or gastroesophageal junction malignant tumors by pathological diagnosis. The diagnosis of distant metastases was advanced gastric cancer by MRI and CT. Gastric cancer patients pathologically diagnosed as HER2-positive received chemotherapy combined with trastuzumab-based standard therapy; patients pathologically diagnosed as HER2-negative received taxane plus platinum-based chemotherapy. All enrolled patients have signed the informed consent.

[0026] 1. Take 6 mL of venous blood from patients with gastric cancer or co...

Embodiment 2

[0033] Example 2 CLDN18.2 + Determination of CTC

[0034] 1. CLDN18.2 + CTC identification criteria:

[0035] After completing the smart scan, the CLDN18.2 + CTCs were identified, and the chromosome 8 aneuploid amplified cells with negative expression of CD45, negative expression of CD31 and positive expression of CLDN18.2 were defined as CLDN18. + CTC); define CD45 negative, CD31 positive and CLDN18.2 positive chromosome 8 aneuploid amplified cells as CLDN18.2 + Circulating Endothelial Cells (CECs).

[0036] 2. CLDN 18.2 exists + Identification of gastric cancer patients with CTC or CEC:

[0037] After completing a single CLDN18.2 + After the identification of CTC and CEC, the total CLDN18.2 in the peripheral blood of each patient with gastric cancer + Count the number of CTC or CEC. Presence of ≥1 CLDN18.2 in peripheral blood + Gastric cancer patients with CTCs or CECs were defined as CLDN18.2 CTC or CEC-positive gastric cancer patients, and vice versa as CL...

Embodiment 3

[0045] Example 3 CLDN18.2 in other samples of patients + The determination of CTC and its relationship with patient survival time (Overall Survival, OS)

[0046] In addition to detecting CLDN18.2-positive CTCs in peripheral blood, the detection method of the present invention can also detect CLDN18.2-positive tumor-related cells in ascites of patients with peritoneal metastatic gastric cancer and use the detected CLDN18.2 Positive for prognosis prediction in gastric cancer patients with peritoneal metastases.

[0047] In malignant tumors, overall survival time is a key indicator used to evaluate the prognosis of cancer patients. OS refers to the time from the start of treatment of malignant tumors to death from any cause in cancer patients. The shorter the OS time of the patients, the better the prognosis of tumor treatment, and vice versa, the worse the prognosis of tumor treatment. We prospectively enrolled 18 patients with intraperitoneal disseminated metastatic gastric ...

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Abstract

According to the invention, CLDN18.2 positive CTC detected in peripheral blood of a patient suffering from advanced gastric cancer or CLDN18.2 positive DTC detected in ascites of a patient suffering from peritoneal metastasis gastric cancer is disclosed for the first time, so that the patient is indicated to have shorter PFS and OS, the treatment effect and total survival of the patient suffering from advanced gastric cancer can be effectively predicted before treatment, only 6 mL of peripheral blood sample of the patient suffering from gastric cancer needs to be extracted during operation, and the operation is simple and convenient. Complex surgery and pathological material taking under an endoscope are not needed, the specimen obtaining process is more minimally invasive and safer, and the method has extremely high popularization value.

Description

technical field [0001] The present invention relates to the field of biological detection, more specifically, the present invention relates to a gastric cancer prognosis biomarker and its application. Background technique [0002] Gastric cancer is one of the malignant tumors that seriously threaten the health of our people. The incidence of gastric cancer in China accounts for about 40% of the world, and the death rate ranks first in the world. To make matters worse, clinical treatment strategies for gastric cancer, especially targeted clinical treatment strategies, are still very limited so far. In 2021, the antibody was developed by Astellas. The FAST study showed that zolbetuximab (a Claudin 18.2 monoclonal antibody) combined with EOX chemotherapy can significantly prolong the PFS time of patients compared with EOX chemotherapy alone (7.5 months: 5.3 months; HR=0.44, 95%CI: 0.29-0.67; P<0.0005) and OS time (13.0 months: 8.3 months; HR=0.55, 95%CI: 0.39-0.77; P<0....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/58
CPCG01N33/57446G01N33/57488G01N33/582G01N2333/705
Inventor 沈琳李一林陈杨李艳艳
Owner BEIJING CANCER HOSPITAL PEKING UNIV CANCER HOSPITAL
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