Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients who are 18 years of age and older and diagnosed with colorectal cancer.

Patients with other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer, etc. as well as Individuals without any diseases checked by colonoscopy.

ColonAiQ test and Colonoscopy

Guoxiang Cai, M.D. Ph.D.

The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.

The accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter, prospective study. Patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. In this study, all cfDNA will be tested by fluorescence quantitative PCR, and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test. Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.

Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection

Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection

Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.

The proportion of participants with colorectal cancer who have positive test results

The proportion of negative test results among participants without CRC and other diseases

Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.

Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection	NCT06347887	Colorectal Canc...	ColonAiQ test a...	18 Years -	Singlera Genomics Inc.
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection	NCT06347887	Colorectal Canc...	ColonAiQ test a...	18 Years -	Singlera Genomics Inc.

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