Clinical trial NCT04287335: Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Official title: Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Adenomatous Polyps
Adenoma
Advanced Adenoma
Keywords: Cancer
Colorectal Cancer
Colorectal Neoplasms
Adenomatous Polyps
Adenoma
Advanced adenoma
Gastrointestinal Diseases
Colonic Diseases
Neoplasms
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Rectal Diseases
Glandular and Epithelial
Neoplasms by Histologic Type
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: New Horizon Health Technology Co., Ltd
name: Beijing Mingze Technology Co., Ltd.
First posted: 2020-02-27
Enrollment: 4758
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with high risk of developing CRC and patients with confirmed CRC

Brief summary: The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.

Detailed description: The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.

Eligibility criteria: Inclusion Criteria:

* Willing to provide written consent
* Able to provide stool sample

For high risk CRC screening group:

* Scheduled for colonoscopy voluntarily or by physician prescription
* CRC high risk profile as defined below:
* History of FIT positivity
* Family history of CRC
* Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress

For CRC group:

* Confirmed CRC patients
* No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures

Exclusion Criteria:

* Unwilling to provide stool samples
* FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
* Prior history of colonoscopy within the past 5 years and removal of lesions
* History of CRC
* other conditions deemed not suited for the study by investigators

Primary outcomes:
measure: Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Kefeng Ding, MD
role: PRINCIPAL_INVESTIGATOR
References: