An observational study in Colorectal Cancer, sponsored by Singlera Genomics Inc.. Completed at 7 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Singlera Genomics Inc. · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 1,965 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Singlera Genomics Inc. is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects 18 years of age and older who are eligible for colorectal cancer diagnosis and scheduled for a screening colonoscopy. more than 1000 subjects are targeted to enroll.
meet one of the following conditions: 1) Suspected colorectal cancer (CRC); 2) Diagnosed with CRC according to clinical diagnostic criteria; 3) Do not have CRC and have interfering diseases:
Exclusion Criteria:
Patients who are 18 years of age and older and diagnosed with colorectal cancer.
Diagnostic Test: ColonAiQ test and Colonoscopy
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.
Diagnostic Test: ColonAiQ test and Colonoscopy
Diagnostic Test
Sensitivity for colorectal cancer with ColonAiQ test
The proportion of participants with colorectal cancer who have positive test results
Time frame: Up to 32 months
Specificity for colorectal cancer with ColonAiQ test
The proportion of negative test results among participants without CRC and other diseases
Time frame: Up to 32 months
PPV for colorectal cancer with ColonAiQ test
Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.
Time frame: Up to 32 months
NPV for colorectal cancer with ColonAiQ test
Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.
Time frame: Up to 32 months
Plan to share: Undecided — Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Singlera Genomics Inc.