The Relationship between the Methylated Septin‐9 DNA Blood Test and Stool Occult Blood Test for Diagnosing Colorectal Cancer in Taiwanese People

Abstract

Background: Colorectal cancer (CRC) is a common and lethal disease in the world. There is an increasing number of cases in Taiwan and a higher rate at advanced stages. The immune fecal occult blood test (iFOBT) has been used as a screening method in Taiwan for years. A new novel diagnostic tool, the Methylated Septin-9 (MS-9) DNA blood test, had been reported to have high sensitivity and specificity for CRC detection. There are no available data in Taiwan, so we conducted this prospective randomized trial to investigate the relationship among the MS-9 DNA blood test, iFOBT, and a combination of the two tests for diagnosing CRC in Taiwanese people. Methods: From July 1, 2012 to December 31, 2013, we prospectively selected 60 plasma samples from patients who were diagnosed with CRC and otherwise, the healthy group by colonoscopy in our hospital. Patients were divided into the CRC group and healthy group. CRC stages 0, I, II and stages III and IV were separately analyzed. We calculated the sensitivity and specificity of each group to determine the relationship among the MS-9 DNA blood test, iFOBT, and a combination of the two tests for diagnosing CRC in Taiwanese people. Results: The results of the MS-9 DNA blood test for the 60 samples were divided into three groups, and the sensitivity as well as the specificity of the MS-9 DNA blood test to detect CRC were 47% and 89%, respectively. The results of iFOBT were also divided into three groups, and had higher sensitivity (84%) but lower specificity (55%) using iFOBT to detect CRC. Higher rates could be predicted to detect CRC if both the tests were positive. Conclusions: A combined MS-9 DNA blood test and iFOBT may help in a higher detection rate of CRC. It could be offered to individuals who are unwilling or unable to undergo colonoscopy. Further large prospective, randomized studies are needed in the future.

A pooled analysis of the diagnostic efficacy of plasmic methylated septin-9 as a novel biomarker for colorectal cancer

“…The following 15 eligible studies then received full text evaluation and 1 of them was eliminated due to lack of relevance (26). Finally, 14 cohorts comprising 23 single studies were enrolled for the meta-analysis (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17).…”

“…Among the methylated genes in CRC, septin-9 has been highlighted as an ideal candidate biomarker (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19). Septin-9 was initially identified in myeloid neoplasia (20).…”

“…It acts as a suppressor gene in numerous cancer types (21,22). In previous years, an increasing number of studies have focused on the investigation of plasma methylated septin-9 for the detection of CRC (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). Consequently, several types of assay kits regarding methylated septin-9 are being developed and have become commercial products.…”

Fecal immunochemical tests in combination with blood tests for colorectal cancer and advanced adenoma detection—systematic review

“…Of 2054 unique articles, 26 were given full text assessment and eight of them were included in our systematic review. [13][14][15][16][17][18][19][20] The 18 articles excluded after full-text review did not report sensitivities and specificities for FIT combined with a blood test. Among the suitable articles, one 16 was entirely based on an asymptomatic CRC screening population.…”

“…Two authors (TN and KW) independently extracted data on study characteristics and outcomes from relevant articles. [13][14][15][16][17][18][19][20] Eventual discrepancies were resolved by consensus. Sensitivities were extracted separately for CRC and AA.…”