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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347887
• Other study ID #: SGI-PCR-01
• Status: Completed
• Start date: May 31, 2021
• Est. completion date: January 16, 2024

Study information

• Verified date: March 2024
• Source: Singlera Genomics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1965
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old, gender is not limited;

2. 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:

1. Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;

2. Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;

3. diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);

3. The subject or his/her guardian is able to understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent.

Exclusion Criteria:

1. People who cannot tolerate relevant tests for clinical diagnosis;

2. Pregnant women;

3. Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;

4. Other conditions deemed unsuitable for inclusion by the investigator.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• ColonAiQ test and Colonoscopy
Diagnostic Test

Locations

Country	Name	City	State
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang
China	Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)	Jinan	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Xi'an Daxing Hospital	Xi'an	Shanxi
China	Xi'an Gaoxin Hospital	Xi'an	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Singlera Genomics Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for colorectal cancer with ColonAiQ test	The proportion of participants with colorectal cancer who have positive test results	Up to 32 months
Primary	Specificity for colorectal cancer with ColonAiQ test	The proportion of negative test results among participants without CRC and other diseases	Up to 32 months
Secondary	PPV for colorectal cancer with ColonAiQ test	Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.	Up to 32 months
Secondary	NPV for colorectal cancer with ColonAiQ test	Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.	Up to 32 months