System, model and kit for evaluating thyroid nodule malignancy degree or probability

A technology for thyroid nodules and malignancy, applied in the field of medical testing, can solve problems such as the inability to accurately determine whether there is a suspicion of malignancy, and no obvious improvement after overtreatment

Active Publication Date: 2022-04-29
西湖欧米(杭州)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In other words, these two methods can only classify some benign nodules very well, and cannot accurately determine whet

Method used

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  • System, model and kit for evaluating thyroid nodule malignancy degree or probability
  • System, model and kit for evaluating thyroid nodule malignancy degree or probability
  • System, model and kit for evaluating thyroid nodule malignancy degree or probability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Example 1—Establishment of a clinical multicenter prospective cohort.

[0070] First, establish a national multi-center clinical trial for sample collection.

[0071] Inclusion criteria:

[0072] (1) Age ≥ 18 years old, ≤ 70 years old;

[0073] (2) Treatment-naïve patients with thyroid nodules without drug treatment;

[0074] (3) Thyroid nodules ≥ 5 mm, thyroid fine needle aspiration, Bethesda III / IV;

[0075] (4) Total / partial thyroidectomy with histological report of corresponding cytopathological puncture nodules;

[0076] (5) Patients voluntarily participate in the research after informed consent.

[0077] Exclusion criteria:

[0078] (1) Patients without surgery;

[0079] (2) Insufficient sample size;

[0080] A total of 3120 samples were collected in this study. After excluding the samples that did not meet the standards, the remaining 2450 samples were used for sample pre-processing and data collection.

Embodiment 2

[0081] Example 2—FNA sample processing method assisted by pressure circulation system.

[0082] FNA puncture samples were obtained by ultrasound guidance or intraoperative repeated aspiration and puncture using a 19-27 g syringe needle. The puncture samples were first lysed by 0.5 mL red blood cell lysate at a low temperature of 4 °C, reacted for 5 min, put into a centrifuge, and centrifuged at 300 g for 10 min. After centrifugation, discard the solution and retain the cells remaining after centrifugation.

[0083] Subsequently, PCT technology samples were used for pretreatment.

[0084] PCT is an emerging semi-automated sample preparation technology for tissue lysis and protein and peptide extraction, in a small volume (150 microliters) container, through ultra-high pressure (up to 45k psi) and standard atmospheric pressure circulation to promote tissue and cells. Dissolves, accelerates proteolysis and enzymatic hydrolysis. The main feature of PCT is the semi-automatic p...

Embodiment 3

[0087] Example 3 - Selection of candidate proteins.

[0088] In this embodiment, candidate peptides and corresponding parent and child ions that are beneficial to the determination of benign and malignant thyroid nodules are screened out.

[0089] i) 14 protein combinations and 20 protein combinations discovered in previous studies;

[0090] ii) The model in the previous study selected 49 proteins for the diagnosis of follicular carcinoma and follicular adenoma;

[0091] iii) Differential proteins between follicular carcinoma and follicular adenoma obtained from the data in previous studies;

[0092] iv) 47 proteins stained by immunohistochemistry in clinic;

[0093] v) 76 proteins related to thyroid cancer reported in the literature;

[0094] After the inventors combined the proteins obtained through the above channels, the initial candidate pool covered a total of 212 proteins.

[0095] Next, the inventors screened 121 proteins and 537 parent-child ion pairs as the par...

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Abstract

The invention relates to a system, a model and a kit for evaluating the malignancy degree or probability of thyroid nodules. The method comprises the following steps: processing a fine needle puncture tissue biopsy sample by adopting a pressure circulation technology, detecting proteomics data of target protein or polypeptide in the obtained sample by adopting a high performance liquid chromatography method and a mass spectrometry method, processing peptide fragment peak area information of the mass spectrometry data, and carrying out AI modeling, the method obtains a final evaluation result (malignant probability), can provide a reference for the thyroid nodule malignant degree for clinic, and also can provide a second evaluation result (malignant probability) for doctors for thyroid nodules which cannot be clinically identified in the prior art. The invention also provides a corresponding kit, a system, an evaluation model and related uses.

Description

technical field [0001] The invention relates to the field of medical detection, and in particular to a method for evaluating the malignancy of thyroid nodules based on targeted detection of proteins or polypeptides and machine learning. Background technique [0002] Thyroid nodules (Thyroid Nodules) is a common clinical disease, according to the autopsy report, the incidence of thyroid nodules in the general population is about 50% to 60%, mostly in women. The vast majority of patients with thyroid nodules have no clinical symptoms and are often found through physical examination or self-touch. Among the thyroid nodules found by pathological examination, only 5% to 15% of the nodules are malignant nodules, that is, thyroid cancer. [0003] The evaluation of thyroid nodules recommended by current clinical guidelines is mainly based on the following three points: first, high-resolution ultrasound, second, blood biochemical indicators, and third, fine needle aspiration biopsy ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/72G01N30/86G01N33/68G06N20/00G16B5/00G16B40/00
CPCG01N30/02G01N30/72G01N30/8675G01N33/6848G16B5/00G16B40/00G06N20/00
Inventor 郭天南朱怡孙耀庭陈晨葛伟刚胡一凡许路昂
Owner 西湖欧米(杭州)生物科技有限公司
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