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A gastric cancer prognostic biomarker and its application

A gastric cancer and prognosis technology, applied in biological testing, biological material analysis, instruments, etc., can solve problems such as inability to achieve accurate monitoring and single-cell phenotype monitoring of CTCs, and achieve a minimally invasive and safe specimen acquisition process. Process more, predict the effect of treatment efficacy

Active Publication Date: 2022-07-08
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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  • A gastric cancer prognostic biomarker and its application
  • A gastric cancer prognostic biomarker and its application
  • A gastric cancer prognostic biomarker and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Method for isolation and identification of patient samples

[0025] Ninety-two patients with advanced gastric cancer who were treated in the Department of Gastrointestinal Oncology of Peking University from November 2017 to May 2021 were prospectively enrolled. Among them, 52 were male patients and 40 were female patients. Sixty-nine patients were ≤60 years old and 23 patients were >60 years old. All patients were diagnosed with advanced gastric or gastroesophageal junction malignancy by pathological diagnosis. Advanced gastric cancer was diagnosed with distant metastases by MRI and CT. Pathologically confirmed HER2-positive gastric cancer patients received standard therapy combined with trastuzumab-targeted therapy; pathologically confirmed HER2-negative patients received taxane combined with platinum-based chemotherapy. All the enrolled patients signed the informed consent.

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

Embodiment 2

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

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

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

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

[0037] On completion of a single CLDN18.2 + After the identification of CTCs and CECs, the total CLDN18.2 + The number of CTCs or CECs was counted. 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 can...

Embodiment 3

[0045] Example 3 CLDN18.2 in other samples of patients + 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 metastases from gastric cancer, and use the detected CLDN18.2 Positive for prognosis prediction of gastric cancer patients with peritoneal metastases.

[0047] In malignant tumors, overall survival time is a key indicator used to evaluate the prognosis of tumor patients. OS refers to the time from the initiation of treatment for the malignancy to death from any cause in a tumor patient. We prospectively enrolled 18 patients with intraperitoneal disseminated and metastatic gastric cancer who received palliative care at Peking University Cancer Hospital from August 2019 to September 2020. The ascites of CLDN18.2-posit...

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Abstract

The present invention discloses for the first time the detection of CLDN18.2-positive CTCs in peripheral blood of patients with advanced gastric cancer or the detection of CLDN18.2-positive DTCs in ascites of patients with peritoneal metastases of gastric cancer, indicating that the patients have shorter PFS and OS, and can effectively prevent The treatment efficacy and overall survival of patients with advanced gastric cancer are predicted before treatment, and only 6 mL of peripheral blood samples from gastric cancer patients are required to be extracted during the operation, and complex surgery and endoscopic pathological sampling are not required. The sample acquisition process is more minimally invasive and safe. Very high promotion value.

Description

technical field [0001] The present invention relates to the field of biological detection, and more particularly, 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's total, and the mortality rate ranks first in the world. To make matters worse, the 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 could 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%...

Claims

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Application Information

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Patent Type & Authority Patents(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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