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

NCT06347887 | Completed DMC

• 1 other identifier: SGI-PCR-01
• Study Type: observational
• Target: 1,965
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PPV for colorectal cancer with ColonAiQ test

  Up to 32 months

• NPV for colorectal cancer with ColonAiQ test

  Up to 32 months

Study Arms (2)

Colorectal cancer group

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

Diagnostic Test: ColonAiQ test and Colonoscopy

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

Interventions

ColonAiQ test and Colonoscopy DIAGNOSTIC_TEST

Diagnostic Test

Colorectal cancer group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years old, gender is not limited;
• 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:
• Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
• Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
• diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
• 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.

You may not qualify if:

• People who cannot tolerate relevant tests for clinical diagnosis;
• Pregnant women;
• Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;

Sponsors & Collaborators

• Singlera Genomics Inc.: lead

Study Sites (7)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)

Jinan, Shandong, 250000, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Xi'an Daxing Hospital

Xi’an, Shanxi, 710000, China

Location

Xi'an Gaoxin Hospital

Xi’an, Shanxi, 710000, China

Location

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Guoxiang Cai, M.D. Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 4, 2024
• Study Start: May 31, 2021
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-03

Locations

CN (7)