Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
  • G01N1/18—Devices for withdrawing samples in the liquid or fluent state with provision for splitting samples into portions
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
  • G01N33/5091—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing the pathological state of an organism
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2800/00—Detection or diagnosis of diseases
  • G01N2800/50—Determining the risk of developing a disease
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2800/00—Detection or diagnosis of diseases
  • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2800/00—Detection or diagnosis of diseases
  • G01N2800/70—Mechanisms involved in disease identification
  • G01N2800/7023—(Hyper)proliferation
  • G01N2800/7028—Cancer

Definitions

• the present invention relates to medical science and namely - to cancer screening and can be applied to performance of non-invasive pre-clinical diagnostics of oncological diseases and obligate forms of precancerous diseases based on the analysis of saliva as well as to assessment of the prognosis of transfer of the non-obligate forms of precancerous diseases into the cancer, and monitoring of the dynamics of the objective health status of the patient subject to treatment.
• the body fluid of the patient saliva
• MAN method monochromatic analysis of the particles
• hydrodynamic radii of the particles and their contribution to the light scattering are determined and the disease is diagnosed based on the value of the aggregate diagnostic parameter.
• the size of the particles of 1 to 25 nm is used as the aggregate diagnostic parameter of the MAN method at their contribution to the light scattering of up to 35% meaning practically healthy, from 36% to 55% meaning the non-obligate precancerous disease, and from 56% to 90% meaning a malignant neoplasm.
• the invention provides for early non-invasive diagnostics of oncological diseases in 12 months prior to occurrence of clinical symptoms of the disease at availability of the aforementioned objective variations in the OPS subfractional composition.
• the general blood analysis which includes measurement of the erythrocyte sedimentation rate (ESR).
• ESR erythrocyte sedimentation rate
• High sensitivity of the analysis is based on variation of the spatial structure of blood plasma proteins at various diseases and statuses, including primarily inflammatory and oncological specific diseases.
• the applied method of capillary measurement of the erythrocyte sedimentation rate within 1 hour provides us with indirect information in relation to the disease pathogenesis, which information is contained in the hydrodynamic size of the blood plasma protein structures.
• the objective of the present invention is in development of a non-invasive and accurate method for nanodiagnostics and making prognoses in relation to the oncological diseases.
• the result of the invention is in detection of quantitative characteristics of the OPS particles, which are typical for obligate forms of precancerous diseases and malignant neoplasms, as well as in the prognostic value (probability of cancer detection during the carcinogenesis in 12 months prior to occurrence of the first clinical signs of the disease) and in the possibility of applying the method to monitoring of the objective health status of the patients undergoing a multiple treatment.
• the investigated sample is centrifuged within 15-20 minutes at the rate of 2,000-3,000 rpm;
• the OPS are sampled on an empty stomach in 3-4 hours after eating the last meal.
• Preliminary rinsing of oral cavity with water is performed before taking swabs from the oropharyngeal. Thereafter, thorough rinsing of the oropharyngeal (during 10-15 seconds) is performed with 25-40 ml of isotonic solution of potassium chloride. The fluid is gathered into the 50 ml vial with the help of the funnel.
• Storage of the OPS samples is performed in the room temperature during 6 hours; at the temperatures from 2°C to 8°C - during 3 days; at the temperature of minus 20°C - during 1 week, and at the temperature of minus 70°C - continuously.
• Investigation of the OPS is performed using the monochromatic analyzer of nanoparticles within a broad range of the nanoparticle sizes - from 1.0 nm to 10,000 nm - with the help of dynamic light scattering of the light beats at backscatter with analyzing the spectral density of the power of Doppler shifts generated by the Brownian motion of the dispersive phase nanoparticles.
• the MAN system is applicable to studying OPS and other biological fluids of the human body in the solutions within the limits of the nanoparticle size range from 1.0 to 10,000 nm. Minimum sample amount is 1 ml.
• the principle of heterodyne retroflection which is characterized by a high value of resolution in the nanoscale, is applied.
• the samples of saliva possessing high concentration of nanoparticles can be measured without any distortions due to the effect of multiple reflections. Measurements of the OPS samples having high and low concentration are possible without preliminary dilution. In addition to distribution of the particles by size, it is determined a relative contribution into light scattering from the part of various fractions.
• the suggested method could be applied under the condition of mass medical examinations of the population in the clinics and laboratory centers possessing monochromatic analyzers of nanoparticles (MAN) and adapted to providing solutions to the problems of studying minimized amounts of OPS.
• MAN monochromatic analyzers of nanoparticles
• the claimed method allows detection and assessment of changes in the homeostasis regulatory system providing, at the same time, for high-precision, expressly performed and non- invasive in relation to the investigated system mode of measurements.
• the studies are performed with a minimum amount of OPS, the preparative stage of which provides for preservation of the unique native structure of its particles, and prompt recording of the mathematically processed results.
• the determined after long-term observation values of such diagnostic parameter like hydrodynamic radii of the OPS particles along with the ratio between the particles of various sizes within the structure of OPS allows performing with a high degree of trustworthiness early diagnostics of the obligate forms of precancerous diseases (chronic atrophic gastritis, polyps of sigmoid colon and rectum, fibrosing adenosis, multiple gastric polyps etc.) and malignant neoplasms.
• precancerous diseases chronic atrophic gastritis, polyps of sigmoid colon and rectum, fibrosing adenosis, multiple gastric polyps etc.
• the claimed method is performed in the following manner.
• the oropharyngeal swabs are sampled on an empty stomach in 3-4 hours after eating the last meal.
• Preliminary rinsing of oral cavity with water is performed before taking swabs from the oropharyngeal.
• thorough rinsing of the oropharyngeal is performed with 25-40 ml of isotonic solution of potassium chloride.
• the fluid is gathered into the 50 ml vial with the help of the funnel, the content of which is put into 3 volumes of the normal saline solution placed into the plastic conical Eppendorf centrifuge flask with the capacity of 0.7 ml.
• the sample is centrifuged during 5 minutes at the rate of 2,500 rpm, and the amount of 100 pl taken from the supernatant fluid is transferred into a clean flask of the same type with a tightly closed plastic cap. All the above procedures are performed in the room temperature.
• the processed sample of the diluted OPS is subject to investigation by the laser correlation spectrometer or frozen in the deep freezing chamber of the refrigerator and stored in this manner until the investigation starts. Before taking the measurements, once frozen sample is incubated in the room temperature within 15-20 minutes (until it defrosts completely), then, after adding of 0.3-0.4 ml of normal saline solution, it is thoroughly centrifuged in the tabletop centrifuge at the rate of 2,500 rpm during 15 minutes.
• the supernatant fluid is sampled and placed into the measuring cuvette of the spectrometer. Spectrum buildup is performed within 8 minutes (up to 800,000 buildups). On the basis of matching the obtained distribution of the particles by size with the reference data bank having good statistical validity, it is determined belonging of the given sample to one or another type (pre-cancerous or malignant neoplasm) of the disease.
• the process of malignant transformation is expected at the patient under study.
• the malignant neoplasms are diagnosed at the patient under study.
• a conclusion about non-availability of the given diseases is made.
• the precancerous process (atrophic gastritis, gastric mucosa polyposis) detected in 12 months after performance of additional examination malignized into the stomach cancer after another 6 months. The diagnosis was confirmed by the results of cytological study performed with the biopsy materials.
• the claimed method allows providing for early trustworthy diagnostics of cancer and precancerous disease due to determining of the value of the diagnostic parameter, performing assessment of the malignant transformation prognosis in 12 months prior to occurrence of the malignant transformation, executing monitoring of the health status of the patient in its dynamics at the background of the treatment procedures that is crucially important for increasing the efficiency of treatment of oncological diseases and forming up of the groups of enhanced oncological risk with respect thereof.

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• Health & Medical Sciences (AREA)
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• Immunology (AREA)
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• Molecular Biology (AREA)
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• Investigating Or Analysing Materials By Optical Means (AREA)
• Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

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• 2020
  • 2020-09-18 RU RU2020130856A patent/RU2738563C1/ru active
• 2021
  • 2021-01-29 WO PCT/RU2021/000036 patent/WO2022060243A1/en active Application Filing

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