NCT05587452

Brief Summary

To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 17, 2022

Last Update Submit

October 20, 2022

Conditions

Colorectal AdenomaColorectal Cancer

Keywords

Colorectal cancerEarly screeningMulti-omicsctDNAArtifical intelligence

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Sensitivity (for colorectal cancer and\\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.

    Through study completion, an average of 1 year

  • Specificity

    Specificity (for colorectal cancer and\\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.

    Through study completion, an average of 1 year

Study Arms (3)

Healthy group

People without colorectal adenoma or cancer

Diagnostic Test: ColonoscopyDiagnostic Test: Test of ctDNA methylationDiagnostic Test: Test of characteristics of ctDNA fragment

Advanced adenoma group

People with colorectal adenoma

Diagnostic Test: ColonoscopyDiagnostic Test: Test of ctDNA methylationDiagnostic Test: Test of characteristics of ctDNA fragment

Colorectal cancer group

People with colorectal cancer

Diagnostic Test: ColonoscopyDiagnostic Test: Test of ctDNA methylationDiagnostic Test: Test of characteristics of ctDNA fragment

Interventions

ColonoscopyDIAGNOSTIC_TEST

Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer

Advanced adenoma groupColorectal cancer groupHealthy group
Test of ctDNA methylationDIAGNOSTIC_TEST

A specified panel is used to detect the site of methylation of ctDNA in plasma

Advanced adenoma groupColorectal cancer groupHealthy group
Test of characteristics of ctDNA fragmentDIAGNOSTIC_TEST

Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment

Advanced adenoma groupColorectal cancer groupHealthy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heathy group: Patients without colorectal adenoma or cancer examined by colonoscopy Precancerous group: Patients at least meet one of the following conditions: ① Diameter \>10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia Colorectal cancer group: Patients diagnosed with adenocarcinoma by colonoscopy and histological examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beiijing Fengtai Hospital

Beijing, Beijing Municipality, China

RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, China

RECRUITING

Affiliated Hospital of Weifang Medical University

Weifang, Shandong, China

RECRUITING

Heji Hospital affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Jianqiang Tang, Dr.

CONTACT

+8613661090036doc_tjq@hotmail.com

Mingguang Zhang, Dr.

CONTACT

+8613261967603zmgslimshady@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

CN(5)