Clinical trial NCT05508503: A Study on a Blood-based Dual-target Test for CRC Detection
Official title: Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer: a Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Adenoma
Keywords: ctDNA
Methylation
Diagnostic test
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Qilu Hospital of Shandong University
name: Wuhan Union Hospital, China
name: Henan Provincial People's Hospital
First posted: 2022-08-19
Enrollment: 1378
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer or subjects who referred to the outpatient and received colonoscopy.

Brief summary: To evaluate the effectiveness and accuracy of the ctDNA dual-target test kit in a large case-control cohort for the detection of colorectal cancer and advanced adenomas.

Detailed description: Usually, colorectal cancers (CRCs) diagnosed in their early stages are curable, especially precancerous lesions (adenomas, polyps) that can be removed during a colonoscopy.However, due to low patient compliance and limited resources, colonoscopy is not feasible for screening the average-risk population. gFOBT/FIT are limited by their low sensitivity and high false-positive rate. Compared to colonoscopy and stool DNA tests, blood-based methylation tests showed greater patient compliance and convenience. Hypermethylated NTMT1 and MAP3K14-AS1 were found in multiple cohorts of CRC samples in our previous study. In this study, we aimed to evaluate the effectiveness and accuracy of the ctDNA dual-target(NTMT1 and MAP3K14-AS1) test kit in 5 tertiary hospitals around china for the detection of colorectal cancer and advanced adenomas. Fecal immunochemical test (FIT) will also privided to participants in the study. Sanger sequencing would be performed to evalute the accuracy of the dual-target methylation detection test kit.

Eligibility criteria: Inclusion Criteria:

1. Inclusion Criteria for CRC group（≥30%） 1)Patients with colorectal cancer 2)Follow-up sample subjects: Subjects who underwent resection of colorectal cancer lesions.
2. Inclusion Criteria for Control group（≤70%） Health volunteer, or subject with other diseases or physiological conditions other than colorectal cancer, including but not limited to gastritis, gastric cancer, esophagitis, rheumatoid arthritis, prostate cancer, microbes (inflammation patients), gastrointestinal bleeding, drugs (typical digestive tract medication) Population), neuroendocrine cancer, squamous cell carcinoma (squamous squamous cell carcinoma, esophageal squamous cell carcinoma);

Exclusion Criteria:

1. Patients who had undergone radical resection of bowel cancer (except for postoperative follow-up) and those who had received anti-tumor therapy such as radiotherapy/chemotherapy；
2. Colorectal cancer or colorectal adenoma with other malignancies；
3. Postoperative follow-up patients of colorectal cance with distant metastasis;
4. The sample size collected did not meet the detection requirements;
5. Other patients who are considered unsuitable for this study (such as pregnancy, high blood pressure, heart disease, etc., who are not suitable for colonoscopy due to physical condition).

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year.
measure: Specificity
timeFrame: Through study completion, an average of 1 year.
measure: Accuracy
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Combined sensitivity
timeFrame: Through study completion, an average of 1 year.
measure: Combined specificity
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital, Navy/Second Military Medical University
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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