Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer

A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03411707

Enrollment

1200

Registered

2018-01-26

Start date

2018-03-19

Completion date

2023-06-30

Last updated

2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenomatous Polyp, Colorectal Cancer

Keywords

Colorectal cancer screening, Stool DNA test, Blood mRNA test

Brief summary

The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination. The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Detailed description

Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Interventions

DIAGNOSTIC_TESTStool DNA test

Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subjects received screening questionnaire and had been defined as high risk. 2. Subjects haven't received any treatment under colonoscopy within 10 years.

Exclusion criteria

1. Subjects are under the usage of specific drugs which might affect the screening test. 2. Subjects had the contraindication for colonoscopy.

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.	6 months

Countries

China

Contacts

Primary ContactHongzhi Zou, MD, PhD

zouhongzhi@creativebio.cn86-020-82510982

Backup ContactYan Qi, PhD

qiyan@creativebio.cn86-020-82510982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026