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Application value of multi-target stool FIT-DNA test (ColoClear) in patients with early colorectal cancer and precancerous lesions and their first-degree relatives: a prospective study

ABSTRACT: Interventions: Gold Standard:Colonoscopy.;Index test:Multi-target stool FIT-DNA test (ColoClear). Primary outcome(s): Sensitivity;Specificity;Positive predictive value;Negative predictive value Study Design: Cohort study

DISEASE(S): Colorectal Cancer

PROVIDER: 2725412 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A prospective study on the application of Multi-target Stool FIT-DNA Test (ColoClear) in colorectal cancer screening and the practical verification of genetic and lifestyle factors

Project description:Interventions: Gold Standard:colonoscopy;Index test:Multi-target Stool FIT-DNA Test (ColoClear) ; Fecal immunochemical test(Pupu Tube) Primary outcome(s): Sensitivity;Specificity;Positive predictive value;Negative predictive value;Coincidence Rate;Morbidity Study Design: Cohort study

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Clinical study of fecal SDC2 / TFPI2 methylation combined with FIT in the detection of colorectal cancer and precancerous lesions

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Associations of NOD2 polymorphisms with Erysipelotrichaceae in stool of in healthy first degree relatives of Crohn's disease subjects.

Project description:BACKGROUND:Genetic analyses have identified many variants associated with the risk of inflammatory bowel disease (IBD) development. Among these variants, the ones located within the NOD2 gene have the highest odds ratio of all IBD genetic risk variants. Also, patients with Crohn's disease (CD) have been shown to have an altered gut microbiome, which might be a reflection of inflammation itself or an effect of other parameters that contribute to the risk of the disease. Since NOD2 is an intracellular pattern recognition receptor that senses bacterial peptidoglycan in the cytosol and stimulates the host immune response (Al Nabhani et al., PLoS Pathog 13:e1006177, 2017), it is hypothesized that NOD2 variants represent perfect candidates for influencing host-microbiome interactions. We hypothesized that NOD2 risk variants affect the microbiome composition of healthy first degree relative (FDR) of CD patients and thus potentially contribute to an altered microbiome state before disease onset. METHODS:Based on this, we studied a large cohort of 1546 healthy FDR of CD patients and performed a focused analysis of the association of three major CD SNPs in the coding region of the NOD2 gene, which are known to confer a 15-40-fold increased risk of developing CD in homozygous or compound heterozygous individuals. RESULTS:Our results show that carriers of the C allele at rs2066845 was significantly associated with an increase in relative abundance in the fecal bacterial family Erysipelotrichaceae. CONCLUSIONS:This result suggests that NOD2 polymorphisms contribute to fecal microbiome composition in asymptomatic individuals. Whether this modulation of the microbiome influences the future development of CD remains to be assessed.

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Stool DNA Testing for opportunistic screening of High-risk Colorectal Cancer population

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Validity and diagnostic performance of an optimized multi-target stool nucleic acid test combined with FIT (ColoAlert 3.0) for early detection of colorectal cancer and advanced precancerous lesions in colon

Project description:Interventions: Group 1: Participants who either have a screening colonoscopy, are referred for diagnostic colonoscopy, or have been diagnosed with a colorectal lesion (therapy-naive) that could be part of this study are eligible for participation in this study. They will be invited to participate in the study when they are referred for colonoscopy (pre-inclusion). After being informed and signing an informed consent form, the subjects will give a stool sample at least two days before the colonoscopy and before the colonic irrigation. The stool sample will be analysed using ColoAlert 3.0. After the colonoscopy, they are assigned to one of the three macroscopically defined groups (CRC, APL or normal colon). However, if the PAD from a biopsy taken under routine conditions does not match the macroscopically defined diagnosis, they are excluded from the evaluation. Subjects who do not belong to one of the 3 groups will also be excluded from the evaluation. Primary outcome(s): • To determine sensitivity for CRC with the ColoAlert 3.0 test • To determine specificity for CRC with the ColoAlert 3.0 test Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other

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