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CN-121978335-A - Plasma biomarker for predicting postoperative recurrence risk of non-small cell lung cancer

CN121978335ACN 121978335 ACN121978335 ACN 121978335ACN-121978335-A

Abstract

The invention relates to a plasma biomarker for predicting postoperative recurrence risk of non-small cell lung cancer and application thereof. The biomarker for predicting the postoperative recurrence risk of non-small cell lung cancer is Thymic Stromal Lymphopoietin (TSLP). The plasma biomarker for predicting the postoperative recurrence risk of the non-small cell lung cancer can be detected by adopting an MSD electrochemiluminescence technology, and the postoperative recurrence risk of the non-small cell lung cancer of a patient can be judged by the concentration of the biomarker in plasma.

Inventors

  • CHENG LEI
  • LI XUEFEI
  • ZHAO CHAO
  • REN SHENGXIANG

Assignees

  • 上海市肺科医院（上海市职业病防治院）

Dates

Publication Date
20260505
Application Date
20260206

Claims (10)

  1. 1. The application of thymic stromal cell lymphopoietin as biomarker or detection reagent in preparing product for predicting recurrence risk after non-small cell lung cancer operation.
  2. 2. The use of claim 1, wherein the reagent detects the concentration of thymic stromal cell lymphopoietin in the sample or detects the transcriptional level of a thymic stromal cell lymphopoietin coding sequence.
  3. 3. The use according to claim 1, wherein the product is a kit or a detection chip.
  4. 4. The use according to claim 1, wherein the sample tested is peripheral blood, plasma or serum of the patient prior to surgery; Preferably, the sample tested is preoperative plasma of the patient.
  5. 5. The use according to any one of claims 1 to 4, wherein the detection is by ELISA, suspension chip, MSD electrochemiluminescence or mass spectrometry; Preferably, the detection employs MSD electrochemiluminescence technology.
  6. 6. A kit for predicting the risk of recurrence of non-small cell lung cancer after surgery, comprising: (1) A specific reagent for detecting thymic stromal cell lymphopoietin, (2) A calibrator, said calibrator being a standard for thymic stromal cell lymphopoietin, and (3) The detection instruction records that the postoperative recurrence risk of the non-small cell lung cancer of the patient is judged by detecting the concentration of thymic stromal cell lymphopoietin in the preoperative plasma of the patient. Preferably, the kit uses MSD electrochemiluminescence technology for detection.
  7. 7. The kit of claim 6, wherein the use procedure comprises: (1) Treating preoperative plasma of a patient, centrifuging, taking supernatant, (2) Detecting the concentration of thymic stromal cell lymphopoietin in the sample by means of said specific reagent using MSD electrochemiluminescence technology, and (3) And judging the postoperative recurrence risk of the non-small cell lung cancer patient according to the concentration of thymic stromal cell lymphopoietin, wherein the recurrence risk is high when the concentration is larger than a threshold value, and the recurrence risk is low when the expression level is smaller than or equal to the threshold value.
  8. 8. An apparatus for predicting the risk of recurrence of non-small cell lung cancer after surgery, the apparatus comprising a memory, a processor, and a computer program stored on the memory and executable on the processor, wherein the processor performs the steps of: (1) Obtaining the concentration of thymic stromal cell lymphopoietin in the preoperative plasma sample, and (2) Predicting the postoperative recurrence risk of the non-small cell lung cancer according to the concentration of thymic stromal cell lymphopoietin in the plasma sample.
  9. 9. A system for predicting the risk of postoperative recurrence of non-small cell lung cancer, comprising: (1) The collecting device is used for obtaining the concentration of thymic stromal cell lymphopoietin in the preoperative plasma sample of the patient, (2) Data processing means for reading the concentration value, and (3) And the judging device is used for predicting the postoperative recurrence risk of the non-small cell lung cancer according to the threshold value.
  10. 10. A method of constructing a model for predicting the risk of recurrence of non-small cell lung cancer after surgery, comprising the steps of: (1) Obtaining the concentration of thymic stromal cell lymphopoietin in a preoperative plasma sample of the patient, and (2) And calculating the ROC curve and the area value under the curve, and determining the threshold value.

Description

Plasma biomarker for predicting postoperative recurrence risk of non-small cell lung cancer Technical Field The invention relates to a plasma biomarker for predicting postoperative recurrence risk of non-small cell lung cancer and application thereof. Background Lung cancer is the leading cause of cancer-related morbidity and mortality. Two major histological subtypes are non-small cell lung cancer (NSCLC) and small cell lung cancer. Surgical resection is part of the standard treatment of patients with early or locally advanced NSCLC. However, postoperative recurrence is common. A systematic literature review and its Meta analysis showed that the recurrence-free survival (RFS) of phase I patients was 96% at 1 year post-operative and reduced to 82% at 5 years post-operative. How to predict the recurrence risk of patients within 5 years after operation before operation, and provide references for treatment decision making, clinical trial design and future research direction, thereby improving the prognosis of NSCLC patients. Cytokines play a key role in regulating the immune system of the body. They can promote or inhibit tumor growth by regulating cell proliferation, metastasis, apoptosis and other relevant signal pathways. Numerous literature reports suggest that a variety of immune and inflammatory related proteins are involved in the development and progression of lung cancer. Electrochemiluminescence (Electrochemiluminescence, ECL) is a specific chemiluminescent reaction initiated electrochemically at the electrode surface, a perfect combination of both electrochemical and chemiluminescent processes. Historically, immunoassays have been performed with a first generation of radioimmunoassay, a second generation of enzyme-linked immunosorbent assay, chemiluminescence, fluorescence and a third generation of electrochemiluminescence. The electrochemical luminescence can replace the sensitivity of the first generation of radioimmunoassay, and inherits the convenience of the second generation of enzyme linked immunosorbent assay, so that the kit is widely accepted and used by a large number of users worldwide. The company Meso Scale Discovery (MSD) has adopted this hypersensitive multifactorial electrochemiluminescence technology. Disclosure of Invention The present invention provides plasma biomarkers for predicting the risk of recurrence after non-small cell lung cancer surgery. The plasma biomarker for predicting the postoperative recurrence risk of non-small cell lung cancer is thymic stromal lymphopoietin (Thymic stromal lymphopoietin, TSLP). In particular, the invention provides a method for predicting the risk of postoperative recurrence of non-small cell lung cancer, comprising the step of detecting the concentration of TSLP in preoperative plasma of a subject. In one or more embodiments, the detection method includes ELISA, suspension chip, MSD electrochemiluminescence technology, or mass spectrometry. Preferably, the detection method is MSD electrochemiluminescence technology. In one or more embodiments, the concentration of TSLP in preoperative plasma of the subject is detected using MSD electrochemiluminescence techniques. In one or more embodiments, when the plasma concentration of the marker is detected using MSD electrochemiluminescence techniques, if the concentration is greater than a threshold, the patient is at a high risk of recurrence after non-small cell lung cancer treatment, and if the concentration is less than or equal to the threshold, the patient is at a low risk of recurrence after surgery after non-small cell lung cancer treatment. The invention also provides application of TSLP as a biomarker or a detection reagent thereof in preparation of a product for predicting postoperative recurrence risk of non-small cell lung cancer. In one or more embodiments, the reagent detects the concentration of TLSP in the sample or detects the transcriptional level of a thymic stromal cell lymphopoietin encoding sequence. In one or more embodiments, the product is a kit or a detection chip. In one or more embodiments, the sample tested is peripheral blood, plasma or serum from a patient prior to surgery. Preferably, the sample tested is the patient's plasma. In one or more embodiments, the reagent is a reagent for detecting a protein using any of ELISA, suspension chip, MSD electrochemiluminescence technology, or mass spectrometry. Preferably, the detection method is MSD electrochemiluminescence technology. The invention also provides a kit for predicting the postoperative recurrence risk of non-small cell lung cancer. In one or more embodiments, the kit comprises: (1) A specific reagent for detecting thymic stromal cell lymphopoietin, (2) A calibrator, said calibrator being a standard for thymic stromal cell lymphopoietin, and (3) The detection instruction, the instruction describes that the risk of postoperative recurrence of a non-small cell cancer patient is judged by detecting the concentrati