Combination test for colorectal cancer

A technology for colorectal cancer and colorectal adenoma, which is applied in the field of detection and screening, and can solve the problems of increased mortality and decreased number of CRC

Inactive Publication Date: 2019-05-21
벨지언볼리션에스알엘
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This would result in fewer people being sent for colonoscopies, but would also result in a reduction in the number of those who did detect CRC, and thus an increase in CRC mortality

Method used

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  • Combination test for colorectal cancer
  • Combination test for colorectal cancer

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0235]1907 people who tested positive in the FIT (fecal occult blood) test and were referred for colonoscopy for this reason gave informed consent to provide blood samples and to use patient data anonymously. Blood samples were collected prior to colonoscopy and analyzed using assays for cell-free nucleosomes, including nucleosomes themselves and DNA containing 5-methylcytosine modifications, the histone variants H2AZ and mH2A1. 1. Histone modifications pH2AX, H2AK119Ub, H3K36Me3, H4K20Me3, H4PanAc, and H3S10Ph, and nucleosomes with epigenetic characteristics of the nucleosome adduct nucleosome-HMGB1 and nucleosome-EZH2.

[0236] All of these nucleosome assays can be used in the methods of the invention. Results from a panel involving 5 nucleosome assays (5-methylcytosine, H2AK119Ub, pH2AX, H3K36Me3, and nucleosome-HMGB1 adduct) together with human numerical FIT levels and age are presented in figure 1 Shown in the ROC curve in , the results were used to discriminate CRC case...

Embodiment 2

[0238] 1907 individuals who tested positive in the FIT (fecal occult blood) test and were referred for colonoscopy for this reason gave informed consent for the use of patient data anonymously. For each individual, enter their fecal hemoglobin (Hb) level (in μgHb / g feces) and patient age (in years) into the expression:

[0239] 0.0129 x FIT level (µg Hb / g feces) + 0.0688 x age (years)

[0240] If the output value of the expression is greater than 4.8, the patient is designated as high risk for CRC and requires colonoscopy. Correspondingly, if the output value of the expression is less than 4.8, the patient is designated as low risk for CRC and does not require colonoscopy.

[0241] Of 118 diagnosed CRC cases, 114 were correctly designated as requiring colonoscopy using this method. Similarly, 222 (88.1%) of 252 high-risk adenoma cases were correctly designated as requiring colonoscopy. The ROC curve showed that at a specificity of 25%, the sensitivity of the method for CRC ...

Embodiment 3

[0243] 599 people who tested positive in the FIT (fecal occult blood) test and were referred for colonoscopy for this reason gave informed consent to provide blood samples and to use patient data anonymously. Blood samples were collected prior to colonoscopy and analyzed for ferritin and CEA. Enter the result of the measure combined with the patient's age and the numeric FIT result into the expression:

[0244] 0.51 x age(years) + 0.17 x CEA (ng / ml) - 17.85 x (5xFIT) -0.1 (µg Hb / g feces) -0.17 x transferrin (ng / ml)

[0245] This expression was set to reduce colonoscopy referrals by 25%. If the output value of the expression is greater than −8.6, the patient is designated as high risk for CRC and requires colonoscopy. Correspondingly, if the expressed output value is less than −8.6, the patient is designated as low risk for CRC and does not require colonoscopy. Of 118 diagnosed CRC cases, 116 were correctly assigned as requiring colonoscopy using this method of the present...

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Abstract

The present invention relates to methods of detecting and / or screening for colorectal cancer (CRC), a colorectal adenoma or a polyp in a patient comprising identifying patients found to be positive for fecal occult blood and further testing for one or more additional factors. Said methods can be used to assess the suitability of a patient for colonoscopy.

Description

field of invention [0001] The present invention relates to methods of detection and screening, in particular methods of screening a patient for colorectal cancer, colorectal adenoma or polyps. Background of the invention [0002] Colorectal cancer (CRC) is a common disease with high mortality. The biology of the disease is understood to involve progression from precancerous adenomas (polyps) with increasing dysplasia, leading to stage I, II, III and eventually stage IV CRC. Mortality varies widely, depending on whether the disease is detected in the early localized stages, when effective treatment options are available, or in the advanced stages, when the disease may spread in or beyond the colon or rectum, when treatment is more effective difficulty. The 5-year survival rate is greater than 90% for those with stage I disease detected, but only about 10% for those with stage IV metastatic disease. For this reason, many countries have CRC screening programs to identify ind...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/68C12Q1/68
CPCC12Q1/6886G01N33/57419G01N33/6875C12Q2600/154C12Q2600/156G01N33/50G01N33/57488G01N33/721G01N2800/70
Inventor J.V.米卡莱夫J.特雷尔
Owner 벨지언볼리션에스알엘
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