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CompletedNCT05508503Updated Feb 16, 2024

A Study on a Blood-based Dual-target Test for CRC Detection

An observational study in Colorectal Cancer and Colorectal Adenoma, sponsored by Changhai Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Changhai Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,378
Sex
All
01

Study 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.

Read the detailed description

Usually, colorectal cancers (CRCs) diagnosed in their early stages are curable, especially precancerous lesions (adenomas, polyps) that can be removed during a colonoscopy.However, due to low patient compliance and limited resources, colonoscopy is not feasible for screening the average-risk population. gFOBT/FIT are limited by their low sensitivity and high false-positive rate. Compared to colonoscopy and stool DNA tests, blood-based methylation tests showed greater patient compliance and convenience. Hypermethylated NTMT1 and MAP3K14-AS1 were found in multiple cohorts of CRC samples in our previous study. In this study, we aimed to evaluate the effectiveness and accuracy of the ctDNA dual-target(NTMT1 and MAP3K14-AS1) test kit in 5 tertiary hospitals around china for the detection of colorectal cancer and advanced adenomas. Fecal immunochemical test (FIT) will also privided to participants in the study. Sanger sequencing would be performed to evalute the accuracy of the dual-target methylation detection test kit.

02

Conditions studied

  • Colorectal Cancer
  • Colorectal Adenoma

Keywords

  • ctDNA
  • Methylation
  • Diagnostic test
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 1,378 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Inclusion Criteria for CRC group（≥30%） 1)Patients with colorectal cancer 2)Follow-up sample subjects: Subjects who underwent resection of colorectal cancer lesions.
  2. Inclusion Criteria for Control group（≤70%） Health volunteer, or subject with other diseases or physiological conditions other than colorectal cancer, including but not limited to gastritis, gastric cancer, esophagitis, rheumatoid arthritis, prostate cancer, microbes (inflammation patients), gastrointestinal bleeding, drugs (typical digestive tract medication) Population), neuroendocrine cancer, squamous cell carcinoma (squamous squamous cell carcinoma, esophageal squamous cell carcinoma);

Exclusion criteria

Exclusion Criteria:

  1. 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；
  2. Colorectal cancer or colorectal adenoma with other malignancies；
  3. Postoperative follow-up patients of colorectal cance with distant metastasis;
  4. The sample size collected did not meet the detection requirements;
  5. 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).
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,378 participants (actual)
Patient registry
No

Groups and cohorts

  • CRC group

    patients with colorectal cancer

    Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1 · Diagnostic Test: FIT

  • Control group

    patients without colorectal cancer

    Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1 · Diagnostic Test: FIT

Interventions

  • Diagnostic testTest of methylated NTMT1 and MAP3K14-AS1

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

  • Diagnostic testFIT

    Fecal immunochemical test（optional）

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 1 year.

  2. 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.

    Time frame: Through study completion, an average of 1 year.

  3. Accuracy

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

    Time frame: Through study completion, an average of 1 year.

Secondary outcomes

  1. Combined sensitivity

    Sensitivity when combined the blood-based methylation dual-target test with FIT

    Time frame: Through study completion, an average of 1 year.

  2. Combined specificity

    Specificity when combined the blood-based methylation dual-target test with FIT

    Time frame: Through study completion, an average of 1 year.

07

Study locations

1 site
  • Changhai Hospital
    Shanghai, Shanghai 200433, China
08

References and documents

Publications

  • 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. PubMed 27392603 ↗
  • 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. PubMed 28600478 ↗
  • 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. PubMed 21400501 ↗
  • 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. PubMed 33585248 ↗
  • 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. PubMed 30377193 ↗

Individual participant data

Plan to share: Undecided — undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05508503
Lead sponsor
Changhai Hospital
Collaborators
The Second Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Henan Provincial People's Hospital
Responsible party
Zhaoshen Li (MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor, Changhai Hospital) — Principal investigator
First posted
Aug 19, 2022
Start date
Oct 21, 2022
Primary completion
Aug 11, 2023
Completion
Aug 11, 2023
Last update
Feb 16, 2024

Study contacts

Zhaoshen Li, MD
principal investigator · Changhai Hospital, Navy/Second Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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