| 摘要 |
Compositions/methods for employing fresh-frozen or FFPE colon cancer tissue in left side colon cancer (LCC) and right-side colon cancer (RCC) disease patients for risk of relapse assessment/stratification is provided (3 strata and a 4 strata methodology). An RCC gene panel of 4 genes (FAM69A, CDX2, FAM84A, ITGA3), and 9 genes (FAM69A, CDX2, ITGA3, FAM84A, ITPRIP, RAB3B, SMAD3, PCSK5, MMP28), is provided. An LCC gene panel of 4 genes (NOX4, WNT5A, MMP3, IBSP), and a 9 genes (MMP3, WINT5A, NOX4, IBSP, SLC16A6, CYPIBI, TFAP2C, MATN3, ANKRD6), is provided. A microchip-based clinical tool, and a kit including a microchip, is presented. The invention also describes a computer-implemented method for assessing relative risk of relapse in LCC and/or RCC disease. An individual patient scoring method that presents a continuous stratification score useful in the post-surgical colon cancer management of LCC and/or RCC patient is also presented. |
| 主权项 |
1. A colon cancer test suitable for assessing a treatment plan for a colon cancer patient having a right side colon cancer (RCC) or a left-side colon cancer (LCC), said test comprising:
obtaining a right side colon cancer (RCC) specimen or a left side colon cancer (LCC) specimen, and performing the following steps: where the patient specimen is a right side colon cancer (RCC) specimen,
measuring expression levels of an RCC panel of 4 to 9 genes that include a gene FAM69A, CDX2, FAM84A and ITGA3 in the patient colon cancer specimen to provide a patient specimen RCC test gene expression level for each of the RCC panel of genes;normalizing each patient specimen RCC test gene expression level against a control gene expression level of an endogenous control gene for colon cancer (YWHAZ gene) to provide a normalized apCR score for each of the RCC test panel genes;calculating an overall apCR patient score from the normalized individual panel gene apCR scores, and scaling the overall apCR patient score to provide a patient continuous risk score (apCR) of from 0 to 100;administering an aggressive post-surgical adjuvant chemotherapy treatment to the RCC patient where the patient continuous risk score (apCR) indicates a higher risk of relapse (continuous risk score apCR 50 to 100), or not administering an aggressive post-surgical adjuvant chemotherapy treatment to the RCC patient where the patient continuous risk score indicates a lower risk of relapse (continuous risk score apCR 0 to less than 25), or screening the LCC patient having a moderate risk of relapse score (continuous risk score apCL 25 to less than 50) for additional cancer risk factors or chemotherapy sensitivities; and/or where the colon cancer specimen is a left side colon cancer (LCC) specimen,
measuring gene expression levels of an LCC panel of 4 to 9 genes that include a MMP3, WINT5A, NOX4, and IBSP gene in the patient colon cancer specimen to provide a LCC test gene level for each of the LCC panel of genes;normalizing each patient specimen LCC test gene expression level against a control gene expression level of an endogenous control gene for colon cancer (YWHAZ) to provide a normalized apCL score for each one of the LCC test panel genes;calculating an overall apCL patient score from the normalized individual panel gene apCL scores, and scaling the overall apCL patient score to provide a patient continuous risk score (apCL) of from 1 to 100; andadministering an aggressive post-surgical adjuvant chemotherapy treatment to the LCC patient where the patient continuous risk score (apCL) indicates a higher risk of relapse (continuous risk score apCL 50 to 100), or not administering an aggressive post-surgical adjuvant chemotherapy treatment to the LCC patient where the patient continuous risk score indicates a lower risk of relapse (continuous risk score apCL 0 to less than 25), or screening the LCC patient having a moderate risk of relapse score (continuous risk score apCL 25 to less than 50) for additional cancer risk factors or chemotherapy sensitivities. |
