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Use of iFOBT in Patients Presenting With Alarm Symptoms of Colorectal Cancer

ABSTRACT: Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units to conduct fast-track colonoscopies is growing. Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from 98%-100%. These results were derived from diverse patient populations, and used different cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when deciding on referral of the patient to the cancer patient pathway. However, evidence is needed on the diagnostic accuracy of the test to detect CRC among patients presenting with alarm symptoms. Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult blood by iFOBT is an accurate measure of the presence of colonic lesions. Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC. Materials and methods: The project is conducted as a diagnostic accuracy study. Patients appointed for colonoscopy will be invited to collect a faecal sample and mail it for analysis. The iFOBT result will be registered in a computer-based laboratory information system. The result of the colonoscopy will be registered in Danish national health registries. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated as measures of the diagnostic properties of the iFOBT, using the result of colonoscopy as the reference standard. The accuracy of the test by type of alarm symptom will also be assessed. Perspectives: The study will provide new and valuable data to evaluate the referral criteria for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice examination in the diagnostic work-up of these patients.

DISEASE(S): Colorectal Carcinoma,Colorectal Adenocarcinoma,Colorectal Adenoma,Colorectal Cancer,Colorectal Neoplasms,Adenoma

PROVIDER: 2260843 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background & Aims. The current staging system for colorectal cancer (CRC) based on TNM classification allows prediction of potential recurrence. However, it does not necessarily make reliable personalized prediction of prognosis. In this paper we describe combination of clinicopathological data and gene signature of dissected tumor specimen with stage II and III CRC patients would improve the situation.. Methods. A total of 1978 CRC were collected over 5 years, and then 371 stage II and 322 stage III of them with more than 45.9 months records were subjected to clinicopathological feature analyses. Out of this collection, 129 stage II and III CRC cases were selected for analyses of gene expression profiles with resected specimen. The gene signatures were analyzed by repeated random divisions of the samples into training and test sets to extract discriminator genes. After testing the applicability of this discriminator set, it was subjected to validation using a newly obtained set of 69 samples. Results. The pathological factors in solo or in combinations could not make personalized recurrence prediction, except for partial success with stage II patients. The gene signature, on the other hand, was capable of producing a set of discriminator genes, though the accuracy was yet to be improved. We observed that the best result was obtained when discriminators were selected from stage II CRC samples and used for prognosis of stage II CRC. When stage III cases were included in the process of discriminator extraction or in the process to validate samples, the results were poorer. Finally, we examined 31 independent stage II samples with a set of 30 such discriminators and were able to obtain results with 78 % accuracy, 90 % negative predictive value (NPV), and 55% positive predictive value (PPV). Conclusions. Independent clinicopathological variables were not able to predict prognosis of individual patient, unless the factors are combined. On the other hand, gene signatures allowed accurate prediction of prognosis for individuals, especially with stage II CRC, suggesting its potential use for selection of best treatment option for individual patients. The accuracy of discriminator prediction will be further improved when we take the evolution of CRC into consideration. Of 198 samples, 129 represented the discovery phase and 69 represented the validation phase.

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Use of iFOBT in Patients Presenting With Alarm Symptoms of Colorectal Cancer

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