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Colorectal CancerNCT05508503

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

An observational study of Colorectal Cancer and Colorectal Adenoma, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer, Colorectal Adenoma
What is being tested?
Test of methylated NTMT1 and MAP3K14-AS1 and FIT
How many people
1,378 participants
Where
1 siteChina
Study dates
21 Oct 2022to 11 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • Inclusion Criteria for CRC group（≥30%） 1)Patients with colorectal cancer 2)Follow-up sample subjects: Subjects who underwent resection of colorectal cancer lesions.
  • 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);

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer: a Multicenter Clinical Study

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.

Being tested
Test of methylated NTMT1 and MAP3K14-AS1, FIT
Keywords
ctDNA, Methylation, Diagnostic test
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test of methylated NTMT1 and MAP3K14-AS1Diagnostic test

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

  • FITDiagnostic test

    Fecal immunochemical test（optional）

Study groups in NCT05508503
Study groupRoleWhat they receive
CRC grouppatients with colorectal cancer
Receives: Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1; Diagnostic Test: FIT
Control grouppatients without colorectal cancer
Receives: Diagnostic Test: Test of methylated NTMT1 and MAP3K14-AS1; Diagnostic Test: FIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Through study completion, an average of 1 year.

Secondary outcomes (2)

  1. Combined sensitivity

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

    Measured: Through study completion, an average of 1 year.

  2. Combined specificity

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

    Measured: Through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start21 Oct 2022
  3. Primary completion11 Aug 2023
  4. Study completion11 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508503
Sponsor's protocol ID
2020CRC-cfDNA
Status last verified
Feb 2024
First submitted
18 Aug 2022
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

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

  • 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.

    PubMed 39379942

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Colorectal Adenoma, run by Changhai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508503, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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