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

NCT ID: NCT03411707

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Colorectal Adenomatous Polyp

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mutiple screening test group

Stool DNA test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Stool 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Blood mRNA test FIT Assay

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role collaborator

Tianjin Nankai Hospital

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Hongzhi Zou

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongzhi Zou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yet-sen University

Locations

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The Sixth Affiliated Hospital, Sun Yet-sen University

Guangzhou, , China

Site Status RECRUITING

Changhai Hospital

Shanghai, , China

Site Status RECRUITING

Tianjin Nankai Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongzhi Zou, MD, PhD

Role: CONTACT

86-020-82510982

Yan Qi, PhD

Role: CONTACT

86-020-82510982

Facility Contacts

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Ping Lan, MD, PhD

Role: primary

Enda Yu, MBBS

Role: primary

Ximo Wang, MD, PhD

Role: primary

Other Identifiers

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SC2017

Identifier Type: -

Identifier Source: org_study_id

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