Method for diagnosing form of bladder cancer in patients with urothelial carcinoma
The method addresses low diagnostic accuracy and invasive procedures in muscle-invasive bladder cancer diagnosis by using microRNA expression levels in a logistic function, achieving high accuracy and avoiding invasive sampling.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- FEDERALNOE GOSUDARSTVENNOE BYUDZHETNOE OBRAZOVATELNOE UCHREZHDENIE VYSSHEGO OBRAZOVANIYA SANKT PETERBURGSKIJ GOSUDARSTVENNYJ PEDIATRICHESKIJ MEDITSINSKIJ UNIV MINISTSTVA ZDRAVOOKHRANENIYA ROSSIJSKOJ FEDERATSII FGBOU VO SPBGPMU MINZDRAVA ROSSII
- Filing Date
- 2025-12-03
- Publication Date
- 2026-06-30
AI Technical Summary
Existing methods for diagnosing muscle-invasive bladder cancer, such as histological examination, face challenges with low diagnostic accuracy when only a small amount of tumor tissue is obtained and require invasive procedures like deep transurethral resection, which may not be feasible for large tumors or require general anesthesia.
A diagnostic method using the expression levels of microRNAs miR-26b, miR-146b, and miR-183, calculated through a logistic function, allows for accurate diagnosis of muscle-invasive bladder cancer even with limited tissue samples, using the formula F = 2.8967*X1+2.1845*X2+3.7345*X3 – 4.1404, where X1, X2, and X3 represent the expression levels of these microRNAs, and U = exp(F)/(1 + exp(F)) determines the probability of muscle-invasiveness.
The method achieves high predictive accuracy with sensitivity of 97.30%, specificity of 89.19%, and diagnostic accuracy of 93.24%, providing reliable muscle-invasive bladder cancer diagnosis without the need for invasive tissue sampling.
Abstract
Description
[0001] The invention relates to medicine, namely, to urology and oncology, and can be used to diagnose muscle-invasive bladder cancer.
[0002] The closest to the claimed method is the diagnosis of muscle-invasive cancer using specialized IHC markers, as well as histological examination of tumor tissue (Clinical guidelines for the diagnosis and treatment of patients with bladder cancer. https: / / oncology-association.ru / wp-content / uploads / 2020 / 09 / rak-mochevogo-puzyrya-1.pdf / / ).
[0003] A disadvantage of the prototype method is that histological confirmation of muscle-invasive bladder cancer in patients with urothelial carcinoma requires deep transurethral resection of the tumor, which requires sampling of the bladder muscle wall. This is not always possible in the presence of a large exophytic tumor component, and also requires general anesthesia. Furthermore, the diagnostic accuracy of muscle-invasive bladder cancer is quite low if only a small amount of tumor tissue is obtained during transurethral resection or cystoscopy.
[0004] The objective of the invention is to improve the accuracy of diagnostics.
[0005] The technical result of the task is achieved by the fact that in the method for diagnosing muscle-invasive cancer in patients with urothelial carcinoma, which consists of a morphological examination of tissues, micro RNA miR-26b, miR-146b, miR-183 are determined and the disease is diagnosed using the formula:
[0006] F = 2.8967*X1+2.1845*X2+3.7345*X3 – 4.1404, where:
[0007] X1 – 0 or 1 depending on the expression level of micro RNA miR-26b,
[0008] X2 – 0 or 1 depending on the expression level of micro RNA miR-146b,
[0009] X3 – with 0 or 1 depending on the expression level of micro RNA miR-183,
[0010] the obtained value F is substituted into the formula:
[0011] U = exp(F) / (1 + exp(F)), where:
[0012] exp – exponential function, the base of the degree is Euler's number 2.72, F is the exponent,
[0013] and if the Y value is higher than 0.5, a muscle-invasive form of bladder cancer is diagnosed, and if the Y value is equal to or lower than 0.5, a non-muscle-invasive form of cancer is diagnosed.
[0014] Assessment of the expression level of miR-26b, miR-146b, miR-183 allows for the diagnosis of muscle-invasive bladder cancer even with a small amount of tumor tissue being examined, which is not always possible using known methods of histological diagnosis of the disease, since the expression of these micro RNAs correlates with the development of tumor cells.
[0015] The Y value is the probability of muscle-invasive bladder cancer from 0 to 100%, where 0.5 is 50%. As Y approaches 1, the probability of muscle-invasive cancer approaches 100%.
[0016] The method is as follows. Tumor tissue is taken and the expression level of three microRNAs is determined: miR-26b, miR-146b, and miR-183. Then, based on the results obtained, a calculation is performed using the formula
[0017] F = 2.8967*X1+2.1845*X2+3.7345*X3 – 4.1404.
[0018] Where X1 is the expression level of miR-26b, with a value of >-457.8 the indicator is 0, with a value of <= -457.8 the indicator is -1.
[0019] X2 - miR-146b expression level indicator: if the value is <= -3.405, the indicator is 0, if the value is > -3.405, the indicator is -1.
[0020] X3 - the expression level of miR-183 at a value of <= -52.36, the indicator is 0, at a value of -52.36, the indicator is -1,
[0021] The obtained value of F is substituted into the formula:
[0022] U = exp(F) / (1 + exp(F)), where:
[0023] exp is the exponential function, the base of the power is Euler's number 2.72, and F is the exponent,
[0024] and if the Y value is higher than 0.5, a muscle-invasive form of bladder cancer is diagnosed, and if the Y value is equal to or lower than 0.5, a non-muscle-invasive form of cancer is diagnosed.
[0025] Example 1. Patient K., 63 years old. Hospitalized at the Leningrad Regional Clinical Oncology Center in September 2025 with a diagnosis of bladder cancer. Tumor tissue was collected.
[0026] Diagnostics were performed using the claimed method. The logistic function equation was:
[0027] F = 2.8967*0+2.1845*1+3.7345*1 – 4.1404= 1.779,
[0028] U = 0.856.
[0029] The risk of muscle-invasive bladder cancer is greater than 85%, resulting in a diagnosis of muscle-invasive bladder cancer. This diagnosis was confirmed by histological examination of the tumor tissue.
[0030] Example 2. Patient B., 68 years old. Hospitalized at the Leningrad Regional Clinical Oncology Center in August 2025 with a diagnosis of bladder tumor. Tumor tissue was collected. Diagnostics were performed using the stated method.
[0031] The equation of the logistic function was:
[0032] F = 2.8967*0+2.1845*0+3.7345*0– 4.1404= -4.1404
[0033] U = 0.016.
[0034] The risk of muscle-invasive bladder cancer is less than 2%.
[0035] Diagnosis: Non-muscle-invasive bladder cancer. This diagnosis was confirmed by histological examination of the tumor tissue.
[0036] The claimed invention demonstrates the potential for effective diagnosis of muscle-invasive bladder cancer. The invention is widely applicable in specialized oncology hospitals.
[0037] The practical significance of the claimed method lies in its increased predictive accuracy (sensitivity – 97.30%, specificity – 89.19%, diagnostic accuracy – 93.24%). The practical significance of the claimed method also lies in the fact that the features characterizing the invention are accessible for study and dynamic monitoring, are easy to define, and the achieved effect significantly exceeds the cost of the expended labor and financial resources. The claimed invention demonstrates the potential for effective diagnosis of muscle-invasive bladder cancer. The invention is applicable for widespread use in specialized (oncology) medical institutions.
Claims
A method for diagnosing a form of bladder cancer in patients with urothelial carcinoma, characterized by the fact that tumor tissue is collected, distinguished by the fact that microRNA miR-26b, miR-146b, miR-183 is determined and the disease is diagnosed using the formula: F = 2.8967⋅X1+2.1845⋅X2+3.7345⋅X3 – 4.1404, where: X1 is the expression level of miR-26b: if the value is > -457.8, the indicator is 0; if the value is ≤ -457.8, the indicator is 1. X2 is the expression level indicator of miR-146b: if the value is ≤ -3.405, the indicator is 0, if the value is > -3.405, the indicator is 1. X3 is the expression level of microRNA miR-183: at a value ≤ -52.36 the indicator is 0, at a value > -52.36 the indicator is 1, the obtained value of F is substituted into the formula: Y = exp(F) / (1 + exp(F)), where: exp is the exponential function, the base of the degree is Euler's number 2.72, F is the exponent, and if the Y value is higher than 0.5, a muscle-invasive form of bladder cancer is diagnosed, and if the Y value is equal to or lower than 0.5, a non-muscle-invasive form of cancer is diagnosed.