Clinical trial NCT06347887: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
Official title: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Singlera Genomics Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 1965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity for colorectal cancer with ColonAiQ test
timeFrame: Up to 32 months
measure: Specificity for colorectal cancer with ColonAiQ test
timeFrame: Up to 32 months
Secondary outcomes:
measure: PPV for colorectal cancer with ColonAiQ test
timeFrame: Up to 32 months
measure: NPV for colorectal cancer with ColonAiQ test
timeFrame: Up to 32 months
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Jinan
country: China
facility: Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Guoxiang Cai, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: