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

Completed

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: ColonAiQ test and Colonoscopy

• Registration Number: NCT06347887
• Lead Sponsor: Singlera Genomics Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-31
• Primary Completion: 2024-01-16
• Study Completion: 2024-01-16
• Status Verified: 2024-03
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1965

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal cancer group	ColonAiQ test and Colonoscopy	Patients who are 18 years of age and older and diagnosed with colorectal cancer.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity for colorectal cancer with ColonAiQ test	Up to 32 months	The proportion of participants with colorectal cancer who have positive test results
Specificity for colorectal cancer with ColonAiQ test	Up to 32 months	The proportion of negative test results among participants without CRC and other diseases

Secondary Outcome Measures

Name	Time	Method
PPV for colorectal cancer with ColonAiQ test	Up to 32 months	Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.
NPV for colorectal cancer with ColonAiQ test	Up to 32 months	Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.

Trial Locations

Locations (7)

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

Xi'an Daxing Hospital; 🇨🇳 Xi'an, Shanxi, China

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Shanxi Provincial People's Hospital; 🇨🇳 Taiyuan, Shanxi, China

Xi'an Gaoxin Hospital; 🇨🇳 Xi'an, Shanxi, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China