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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: ColonAiQ test and Colonoscopy

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 Type: Observational
• Enrollment (Actual): 1965

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710000
      • Xi'an Daxing Hospital
    • Xi'an, Shanxi, China, 710000
      • Xi'an Gaoxin Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal cancer group; Patients who are 18 years of age and older and diagnosed with colorectal cancer.	Diagnostic test: ColonAiQ test and Colonoscopy; Diagnostic Test
Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for colorectal cancer with ColonAiQ test	The proportion of participants with colorectal cancer who have positive test results	Up to 32 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Singlera Genomics Inc.
• Investigators: Principal Investigator: Guoxiang Cai, M.D. Ph.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SGI-PCR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No