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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

ABSTRACT: 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

DISEASE(S): Special Screening Examination For Neoplasm Of Intestinal Tract

PROVIDER: 2727277 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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