NCT05508503

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

August 18, 2022

Last Update Submit

February 15, 2024

Conditions

Colorectal CancerColorectal Adenoma

Keywords

ctDNAMethylationDiagnostic test

Outcome Measures

Primary Outcomes (3)

  • Sensitivity

    Sensitivity (for CRC and\\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases.

    Through study completion, an average of 1 year.

  • Specificity

    Specificity (for CRC and\\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases.

    Through study completion, an average of 1 year.

  • Accuracy

    Accuracy of the kit for methylation detection. Validation of the methylation status of MTNT1 and MAP3K14-AS1 by Sanger sequencing.

    Through study completion, an average of 1 year.

Secondary Outcomes (2)

  • Combined sensitivity

    Through study completion, an average of 1 year.

  • Combined specificity

    Through study completion, an average of 1 year.

Study Arms (2)

CRC group

patients with colorectal cancer

Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1Diagnostic Test: FIT

Control group

patients without colorectal cancer

Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1Diagnostic Test: FIT

Interventions

Test of methylated NTMT1 and MAP3K14-AS1DIAGNOSTIC_TEST

A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples.

CRC groupControl group
FITDIAGNOSTIC_TEST

Fecal immunochemical test（optional）

CRC groupControl group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal cancer or subjects who referred to the outpatient and received colonoscopy.

You may not qualify if:

  • 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；
  • Colorectal cancer or colorectal adenoma with other malignancies；
  • Postoperative follow-up patients of colorectal cance with distant metastasis;
  • The sample size collected did not meet the detection requirements;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (6)

  • Thierry AR, El Messaoudi S, Gahan PB, Anker P, Stroun M. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Sep;35(3):347-76. doi: 10.1007/s10555-016-9629-x.

    PMID: 27392603BACKGROUND

  • Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.

    PMID: 28600478BACKGROUND

  • Oster B, Thorsen K, Lamy P, Wojdacz TK, Hansen LL, Birkenkamp-Demtroder K, Sorensen KD, Laurberg S, Orntoft TF, Andersen CL. Identification and validation of highly frequent CpG island hypermethylation in colorectal adenomas and carcinomas. Int J Cancer. 2011 Dec 15;129(12):2855-66. doi: 10.1002/ijc.25951. Epub 2011 Apr 1.

    PMID: 21400501BACKGROUND

  • Cao Y, Zhao G, Yuan M, Liu X, Ma Y, Cao Y, Miao B, Zhao S, Li D, Xiong S, Zheng M, Fei S. KCNQ5 and C9orf50 Methylation in Stool DNA for Early Detection of Colorectal Cancer. Front Oncol. 2021 Jan 29;10:621295. doi: 10.3389/fonc.2020.621295. eCollection 2020.

    PMID: 33585248BACKGROUND

  • Chen H, Li N, Ren J, Feng X, Lyu Z, Wei L, Li X, Guo L, Zheng Z, Zou S, Zhang Y, Li J, Zhang K, Chen W, Dai M, He J; group of Cancer Screening Program in Urban China (CanSPUC). Participation and yield of a population-based colorectal cancer screening programme in China. Gut. 2019 Aug;68(8):1450-1457. doi: 10.1136/gutjnl-2018-317124. Epub 2018 Oct 30.

    PMID: 30377193RESULT

  • Wang Z, He Z, Lin R, Feng Z, Li X, Sui X, Gu L, Xia T, Zhou D, Zhao B, Li Y, Li Z, Bai Y. Evaluation of a plasma cell-free DNA methylation test for colorectal cancer diagnosis: a multicenter clinical study. BMC Med. 2024 Oct 8;22(1):436. doi: 10.1186/s12916-024-03662-y.

    PMID: 39379942DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhaoshen Li, MD

    Changhai Hospital, Navy/Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 19, 2022

Study Start

October 21, 2022

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

CN(1)